A Phase 3 interventional study of Implant Procedure and Conventional Synthetic DMARD in Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation. Active, not recruiting at 42 sites in United States. Open to participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by SetPoint Medical Corporation · Phase 3, Interventional, and Treatment
The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll up to 250 subjects at up to 45 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
The RESET-RA study is an operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter pivotal study enrolling up to 250 subjects at up to 45 study centers across the U.S. The study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). The implant delivers a small amount of electricity (stimulation) to the nerve. All eligible subjects will undergo the surgery under general anesthesia. Half of the subjects will receive active stimulation (the treatment group) and the other half will receive non-active stimulation (the control group). Stimulation will be delivered for 1 min once per day for 12 weeks. After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 252-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety. Blinding will be maintained until the last enrolled and randomized subject in Stage 2 completes Week 12 assessments, and the study database is locked.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 243 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →SetPoint Medical Corporation is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active stimulation for 1 min once per day
Procedure: Implant Procedure · Drug: Conventional Synthetic DMARD · Device: Active stimulation
Non-active stimulation for 1 min once per day
Procedure: Implant Procedure · Drug: Conventional Synthetic DMARD · Device: Non-active stimulation
The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
Also known as: Surgical placement of vagus nerve stimulator inside the neck
All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent
Also known as: Background therapy with conventional synthetic DMARD
Active stimulation for 1 min once per day
Non-active stimulation for 1 min once per day
the American College of Rheumatology (ACR) 20 Response
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 12
DAS28-CRP Good or Moderate Response as Defined by European League Against Rheumatism (EULAR)
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) good or moderate response as defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 A subject is considered having a moderate treatment response if: * DAS28-CRP score improvement from baseline to Week 12 is \> 0.6 and ≤ 1.2, and the DAS28-CRP score at Week 12 is ≤ 5.1; or * DAS28-CRP score improvement from baseline to Week 12 is \> 1.2, and the DAS28-CRP score at Week 12 is \> 3.2. A subject is considered having a good treatment response if: • DAS28-CRP score improvement from baseline to Week 12 is \> 1.2 and the DAS28-CRP score at Week 12 is ≤ 3.2
Time frame: Week 12
DAS28-CRP Response (MCID -1.2) at Week 12
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) response is based on the minimal clinically important difference (MCID) of -1.2 from baseline. DAS28-CRP is based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96
Time frame: Week 12
Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22)
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 12
ACR20 Response at Week 12 From Day 0
Response is defined as achieving at least 20% improvement from Day 0 to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL).
Time frame: Week 12
Bone Erosion Progression, All Completers
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
Time frame: Week 12
Bone Erosion Progression, All Completers With Erosive Phenotype
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
Time frame: Week 12
Bone Erosion Progression, All Completers That Previously Only Failed 1 b/tsDMARD
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
Time frame: Week 12
Change in Erosion Score, All Completers
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
Time frame: Week 12
Change in Erosion Score, All Completers With Erosive Phenotype
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
Time frame: Week 12
Change in Erosion Score, All Completers That Previously Only Failed 1 b/tsDMARD
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
Time frame: Week 12
Change in Synovitis Score, All Completers
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
Time frame: Week 12
Change in Synovitis Score, All Completers With Erosive Phenotype
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
Time frame: Week 12
Change in Synovitis Score, All Completers That Previously Only Failed 1 b/tsDMARD
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
Time frame: Week 12
Change in Osteitis Score, All Completers
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
Time frame: Week 12
Change in Osteitis Score, All Completers With Erosive Phenotype
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
Time frame: Week 12
Change in Osteitis Score, All Completers That Previously Only Failed 1 b/tsDMARD
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
Time frame: Week 12
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 12
DAS28-CRP Low Disease Activity (LDA) or Remission
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 12
the American College of Rheumatology (ACR) 20 Response, All Completers
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 24
the American College of Rheumatology (ACR) 20 Response, Non-augmented
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 24
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 24
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 24
DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 24
DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 24
Study Participants That Are Somewhat to Very Satisfied With the SetPoint System for Treatment of Rheumatoid Arthritis
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
Time frame: Week 24
Study Participants That Are Neither Satisfied Nor Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
Time frame: Week 24
Study Participants That Are Somewhat to Very Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
Time frame: Week 24
Study Participants That Would Recommend the SetPoint System to a Family Member or Friend
Patients were asked a question about whether they would recommend the SetPoint System to family and friends
Time frame: Week 24
the American College of Rheumatology (ACR) 20 Response, All Completers
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 36
the American College of Rheumatology (ACR) 20 Response, Non-augmented
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 36
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 36
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 36
DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 36
DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 36
Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 36
Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 36
the American College of Rheumatology (ACR) 20 Response, All Completers
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 48
the American College of Rheumatology (ACR) 20 Response, Non-augmented
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 48
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 48
Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
Time frame: Week 48
DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 48
DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
Time frame: Week 48
Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 48
Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
Time frame: Week 48
the American College of Rheumatology (ACR) 20 Response, Subjects With 1 Prior b/tsDMARD
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 12
the American College of Rheumatology (ACR) 20 Response, Subjects With 2 Prior b/tsDMARD
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 12
the American College of Rheumatology (ACR) 20 Response, Subjects With 3 Prior b/tsDMARD
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 12
the American College of Rheumatology (ACR) 20 Response, Subjects With >=4 Prior b/tsDMARD
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
Time frame: Week 12
| Milestone | Treatment | Control |
|---|---|---|
| Started | 122 | 120 |
| Week 12 (primary endpoint) | 122 | 120 |
| Week 24 | 119 | 117 |
| Week 36 | 119 | 115 |
| Week 48 | 119 | 114 |
| Completed | 120 | 116 |
| Not completed | 2 | 4 |
| Withdrew: Device malfunction | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Adverse event | 0 | 2 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment | Control |
|---|---|---|
| the American College of Rheumatology (ACR) 20 Response | 43 | 29 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) good or moderate response as defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 A subject is considered having a moderate treatment response if: * DAS28-CRP score improvement from baseline to Week 12 is \> 0.6 and ≤ 1.2, and the DAS28-CRP score at Week 12 is ≤ 5.1; or * DAS28-CRP score improvement from baseline to Week 12 is \> 1.2, and the DAS28-CRP score at Week 12 is \> 3.2. A subject is considered having a good treatment response if: • DAS28-CRP score improvement from baseline to Week 12 is \> 1.2 and the DAS28-CRP score at Week 12 is ≤ 3.2
| Participants | Treatment | Control |
|---|---|---|
| DAS28-CRP Good or Moderate Response as Defined by European League Against Rheumatism (EULAR) | 74 | 50 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) response is based on the minimal clinically important difference (MCID) of -1.2 from baseline. DAS28-CRP is based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96
| Participants | Treatment | Control |
|---|---|---|
| DAS28-CRP Response (MCID -1.2) at Week 12 | 55 | 39 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment | Control |
|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22) | 56 | 44 |
Response is defined as achieving at least 20% improvement from Day 0 to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL).
| Participants | Treatment | Control |
|---|---|---|
| ACR20 Response at Week 12 From Day 0 | 38 | 27 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
| Participants | Treatment | Control |
|---|---|---|
| Bone Erosion Progression, All Completers | 18 | 21 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
| Participants | Treatment, Erosive Phenotype | Control, Erosive Phenotype |
|---|---|---|
| Bone Erosion Progression, All Completers With Erosive Phenotype | 10 | 17 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows: * Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. * Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. * Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. * CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100. The proportion of bone erosion progressors is the % subjects with an increase of \> 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of \> 0.5 represents disease progression.
| Participants | Treatment, 1 Prior b/tsDMARD | Control, 1 Prior b/tsDMARD |
|---|---|---|
| Bone Erosion Progression, All Completers That Previously Only Failed 1 b/tsDMARD | 3 | 9 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
| score on a scale | Treatment | Control |
|---|---|---|
| Change in Erosion Score, All Completers | 0.2 ± 0.85 | 0.5 ± 1.74 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
| score on a scale | Treatment, Erosive Phenotype | Control, Erosive Phenotype |
|---|---|---|
| Change in Erosion Score, All Completers With Erosive Phenotype | 0.3 ± 1.09 | 1.1 ± 2.51 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
| score on a scale | Treatment, 1 Prior b/tsDMARD | Control, 1 Prior b/tsDMARD |
|---|---|---|
| Change in Erosion Score, All Completers That Previously Only Failed 1 b/tsDMARD | 0.0 ± 0.60 | 0.8 ± 2.57 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
| score on a scale | Treatment | Control |
|---|---|---|
| Change in Synovitis Score, All Completers | 0.0 ± 1.64 | 0.1 ± 1.51 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
| score on a scale | Treatment, Erosive Phenotype | Control, Erosive Phenotype |
|---|---|---|
| Change in Synovitis Score, All Completers With Erosive Phenotype | -0.1 ± 2.27 | 0.0 ± 1.77 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
| score on a scale | Treatment, 1 Prior b/tsDMARD | Control, 1 Prior b/tsDMARD |
|---|---|---|
| Change in Synovitis Score, All Completers That Previously Only Failed 1 b/tsDMARD | 0.1 ± 0.81 | 0.6 ± 1.78 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
| score on a scale | Treatment | Control |
|---|---|---|
| Change in Osteitis Score, All Completers | 0.1 ± 2.61 | 0.8 ± 4.13 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
| score on a scale | Treatment, Erosive Phenotype | Control, Erosive Phenotype |
|---|---|---|
| Change in Osteitis Score, All Completers With Erosive Phenotype | 0.2 ± 3.74 | 1.8 ± 6.18 |
RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
| score on a scale | Treatment, 1 Prior b/tsDMARD | Control, 1 Prior b/tsDMARD |
|---|---|---|
| Change in Osteitis Score, All Completers That Previously Only Failed 1 b/tsDMARD | -0.3 ± 2.22 | 1.1 ± 4.92 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment | Control |
|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission | 28 | 19 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment | Control |
|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission | 31 | 18 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, All Completers | 53 | 65 | 118 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Non-augmented | 50 | 52 | 102 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | 33 | 36 | 69 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | 33 | 31 | 64 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | 36 | 37 | 73 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | 35 | 32 | 67 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | 64 | 72 | 136 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | 56 | 62 | 118 |
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Study Participants That Are Somewhat to Very Satisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | 90 | 92 | 182 |
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Study Participants That Are Neither Satisfied Nor Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | 14 | 12 | 26 |
Patient satisfaction was assessed at Week 24 using five-point Likert rating scale: * I am very dissatisfied * I am somewhat dissatisfied * I am neither satisfied nor dissatisfied * I am somewhat satisfied * I am very satisfied
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Study Participants That Are Somewhat to Very Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | 15 | 10 | 25 |
Patients were asked a question about whether they would recommend the SetPoint System to family and friends
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Study Participants That Would Recommend the SetPoint System to a Family Member or Friend | 108 | 110 | 218 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, All Completers | 57 | 64 | 121 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Non-augmented | 46 | 54 | 100 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | 39 | 40 | 79 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | 34 | 35 | 69 |
Therapy persistence means continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System as a Stand-alone Therapy | 96 | 99 | 195 |
Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corti
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | 17 | 12 | 29 |
Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corticosteroi
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | 9 | 8 | 17 |
Therapy persistence is defined as the continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | 120 | 118 | 238 |
Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Discontinuation of SetPoint System Therapy | 2 | 2 | 4 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | 38 | 40 | 78 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | 31 | 35 | 66 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | 68 | 67 | 135 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | 53 | 51 | 104 |
Therapy persistence means continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System as a Stand-alone Therapy | 89 | 88 | 177 |
Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corti
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | 25 | 22 | 47 |
Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corticosteroi
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | 7 | 9 | 16 |
Therapy persistence is defined as the continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | 120 | 116 | 236 |
Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Discontinuation of SetPoint System Therapy | 2 | 4 | 6 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, All Completers | 61 | 62 | 123 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Non-augmented | 43 | 48 | 91 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | 47 | 41 | 88 |
The CDAI score is based on 4 items: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * EGA, evaluator's global assessment (0=best to 10=worst) The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | 36 | 33 | 69 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | 50 | 42 | 92 |
The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising: * TJC28, tender joint count of 28 joints (scale 0=best to 28=worst) * SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst) * SGA, subject global assessment (0=best to 10=worst) * hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L) A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 \* sqrt(TJC28) + 0.28 \* sqrt(SJC28) + 0.36 \* ln(CRP+1) + 0.014 \* SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity: * 0 to \< 2.6 Remission * 2.6 to \< 3.2 LDA * 3.2 to ≤ 5.1 Moderate activity * \> 5.1 High activity
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | 37 | 32 | 69 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | 66 | 67 | 133 |
HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas: * Dressing and grooming * Arising * Eating * Walking * Hygiene * Reach * Grip * Common daily activities Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability: * 0 to \< 1 Mild difficulties to moderate disability * 1 to \< 2 Moderate disability * 2 to 3 Severe to very severe disability
| Participants | Treatment to Open Label (TOL), Non-augmented | Control to Open Label (COL), Non-augmented | All (TOL Non-augmented+COL Non Augmented) |
|---|---|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | 41 | 49 | 90 |
Therapy persistence means continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System as a Stand-alone Therapy | 77 | 81 | 158 |
Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corti
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | 32 | 28 | 60 |
Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints: * Prednisone equivalent \>10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit. * Corticosteroid injection. If subject received a corticosteroi
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | 16 | 12 | 28 |
Therapy persistence is defined as the continuation of therapy after it is initiated.
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | 120 | 116 | 236 |
Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed
| Participants | Treatment to Open Label (TOL) | Control to Open Label (COL) | All (TOL+COL) |
|---|---|---|---|
| Discontinuation of SetPoint System Therapy | 2 | 4 | 6 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment | Control |
|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Subjects With 1 Prior b/tsDMARD | 23 | 8 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment | Control |
|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Subjects With 2 Prior b/tsDMARD | 8 | 3 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment | Control |
|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Subjects With 3 Prior b/tsDMARD | 3 | 6 |
Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L).
| Participants | Treatment | Control |
|---|---|---|
| the American College of Rheumatology (ACR) 20 Response, Subjects With >=4 Prior b/tsDMARD | 9 | 12 |
Collected over As collected from time of consent through March 10, 2025 (data cut date for Clinical Study Report). This period coverage an average duration of 803 days (2.2 years) for each subject.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/122 (0%) | 22/122 (18%) | 74/122 (60.7%) |
| Control | 0/120 (0%) | 29/120 (24.2%) | 79/120 (65.8%) |
| Event | Treatment | Control |
|---|---|---|
| PneumoniaInfections and infestations | 2/122 | 3/120 |
| CellulitisInfections and infestations | 0/122 | 2/120 |
| Cerebrovascular accidentNervous system disorders | 0/122 | 2/120 |
| Acute kidney injuryRenal and urinary disorders | 2/122 | 1/120 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 0/122 | 1/120 |
| Chest painGeneral disorders and administration site conditions | 0/122 | 1/120 |
| Osteomyelitis acuteInfections and infestations | 0/122 | 1/120 |
| Sternal fractureInjury, poisoning and procedural complications | 0/122 | 1/120 |
| Swollen tongueGastrointestinal disorders | 0/122 | 1/120 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 0/122 | 1/120 |
| Event | Treatment | Control |
|---|---|---|
| COVID-19Infections and infestations | 18/122 | 23/120 |
| Urinary tract infectionInfections and infestations | 8/122 | 10/120 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 10/122 | 8/120 |
| NasopharyngitisInfections and infestations | 10/122 | 5/120 |
| Upper respiratory tract infectionInfections and infestations | 10/122 | 2/120 |
| SinusitisInfections and infestations | 9/122 | 8/120 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 7/122 | 8/120 |
| COVID-19Infections and infestations | 8/122 | 6/120 |
| Vocal cord paresisNervous system disorders | 5/122 | 6/120 |
| InfluenzaInfections and infestations | 3/122 | 6/120 |
| Age, Continuous(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 55.8 ± 10.28 | 55.5 ± 10.49 | 55.7 ± 10.36 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 98 | 110 | 208 |
| Male | 24 | 10 | 34 |
| Ethnicity (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 22 | 45 |
| Not Hispanic or Latino | 98 | 95 | 193 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Race (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 10 | 12 | 22 |
| White | 102 | 93 | 195 |
| More than one race | 5 | 9 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 122 | 120 | 242 |
| Body Mass Index(kg/m2) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 30.7 ± 7.25 | 29.8 ± 6.71 | 30.3 ± 6.98 |
| Rheumatoid arthritis (RA) duration(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 13.0 ± 10.59 | 11.8 ± 10.45 | 12.4 ± 10.52 |
| Clinical Disease Activity Index (CDAI) score(score on a scale) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 36.1 ± 12.60 | 38.2 ± 12.75 | 37.1 ± 12.69 |
13 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No sharing data is planned.
Ran from Jan 2021 to primary completion in May 2024, 40 months.
Results were first posted in Dec 2025, 1 year 7 months after primary completion.
Of 116 industry-sponsored phase 3 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's 40 months is above that.
Counting every sponsor, half of 148 studies reached it within 26 months; a quarter within 17 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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SetPoint Medical Corporation