A Phase 4 interventional study of SARILUMAB and Azathioprine in Rheumatoid Arthritis, sponsored by Sanofi. Completed at 33 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
Primary Objective:
To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.
Secondary Objectives:
The study duration per participant was approximately 32 weeks, with up to 4-week screening, 24 weeks treatment period, and 2-4 weeks post-treatment observations.
Exclusion criteria:
Participants with any of the following laboratory abnormalities at the Screening or Baseline visit:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sarilumab 200 milligram (mg) subcutaneous (SC) injection every 2 weeks (q2w) from Day 1 of Week 0 up to Week 24 as monotherapy and/or in combination with methotrexate (MTX) or other csDMARD during the randomized 6-month (24 weeks) core treatment period. Participants completing 24 weeks period entered in a long-term extension treatment period and received sarilumab 200 mg q2w from Week 25 until the commercial availability of sarilumab in the country or maximum of up to Week 39.7.
Drug: SARILUMAB · Drug: Azathioprine · Drug: Chloroquine · Drug: Hydroxychloroquine · Drug: Leflunomide · Drug: Methotrexate · Drug: Sulfasalazine
Pharmaceutical form:Solution for injection in pre-filled syringe Route of administration: Subcutaneous
Also known as: SAR153191 (REGN88), Kevzara®
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Tablet Route of administration: Oral
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous / Intramuscular
Pharmaceutical form:Tablet Route of administration: Oral
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
Time frame: Baseline, Week 24
Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbances, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological wellbeing, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
Time frame: Baseline, Weeks 4 and 12
Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24
HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24
HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.
Time frame: Baseline, Weeks 4, 12 and 24
Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24
MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a visual analog scale (VAS; in centimeters \[cm\]) ranged from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24
MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a VAS (in cm) ranging from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.
Time frame: Baseline, Weeks 4, 12 and 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24
FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24
FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).
Time frame: Baseline, Weeks 4, 12 and 24
Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24
HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week (at each specified visit) rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24
HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week (at each specified visit) rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.
Time frame: Baseline, Weeks 4, 12 and 24
Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.
Time frame: Baseline, Weeks 4, 12 and 24
International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24
IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in metabolic equivalent (MET)-minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24
IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in MET minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
Time frame: Baseline, Weeks 4, 12 and 24
Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24
PtGA of disease activity was measured using a 100 millimeters (mm) horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24
PtGA of disease activity was measured using a 100 mm horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.
Time frame: Baseline, Weeks 4, 12 and 24
Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24
ESR was a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24
ESR was a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/h.
Time frame: Baseline, Weeks 4, 12 and 24
Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24
DAS28-ESR was a composite score that included 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score less than or equal to (\<=) 3.2 indicated low disease activity (LDA), greater than (\>) 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24
DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score \<= 3.2 indicated LDA, \> 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
Time frame: Baseline, Weeks 4, 12 and 24
Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24
CDAI was a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24
CDAI was a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
Time frame: Baseline, Weeks 4, 12 and 24
Number of Swollen Joints at Baseline, Weeks 4, 12, and 24
Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24
Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
Time frame: Baseline, Weeks 4, 12 and 24
Number of Tender Joints at Baseline, Weeks 4, 12, and 24
Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
Time frame: Baseline, Weeks 4, 12 and 24
Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24
Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
Time frame: Baseline, Weeks 4, 12 and 24
Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24
DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable) marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score \<= 3.2 indicated LDA, \> 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
Time frame: Weeks 12 and 24
Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24
CDAI was a composite index constructed to measure clinical remission in RA that does not included a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment (in cm). Total score ranged from 0 to 76 with a lower score indicated less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
Time frame: Weeks 12 and 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the study treatment. SAE: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks.
Time frame: Baseline up to end of study (up to 39.7 weeks)
The study was conducted at 31 active centers in France. A total of 104 participants were screened between 05 March 2018 to 27 December 2018, of which 20 were screen failures. Screen failures were mainly due to inclusion criteria not met.
| Milestone | Sarilumab |
|---|---|
| Started | 84 |
| Completed | 65 |
| Not completed | 19 |
| Withdrew: Major protocol deviation | 1 |
| Withdrew: Treatment inefficacy | 5 |
| Withdrew: Adverse event | 9 |
| Withdrew: Consent withdrawal | 1 |
| Withdrew: Other unspecified reason | 3 |
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
| score on a scale | Sarilumab |
|---|---|
| Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24 | -2.4 ± 2.3 |
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological well-being, • sleep disturbances, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
| score on a scale | Sarilumab |
|---|---|
| Week 4 | 4.6 ± 2.1 |
| Week 12 | 3.9 ± 2.3 |
| Week 24 | 3.3 ± 2.5 |
RAID was a participant reported outcome measure used to evaluate the impact of RA on participant's quality of life which comprised 7 domains: • pain, • function, • fatigue, • physical and psychological wellbeing, • sleep disturbance, and • coping. Each domain was a single question scored on a 0 to 10 continuous NRS. The values for each of these domains were weighed by participant assessment of relative importance and combined in a single value. Total RAID score range was 0 (not affected, very good) to 10 (most affected), where higher value indicated worse status.
| score on a scale | Sarilumab |
|---|---|
| Week 4 | -1.2 ± 1.6 |
| Week 12 | -1.8 ± 2.2 |
HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.
| score on a scale | Sarilumab |
|---|---|
| HADS-A: Baseline | 8.1 ± 4.3 |
| HADS-A: Week 4 | 7.2 ± 4.3 |
| HADS-A: Week 12 | 6.1 ± 3.7 |
| HADS-A: Week 24 | 6.6 ± 3.9 |
| HADS-D: Baseline | 7.0 ± 3.9 |
| HADS-D: Week 4 | 6.6 ± 4.0 |
| HADS-D: Week 12 | 5.7 ± 4.1 |
| HADS-D: Week 24 | 5.5 ± 4.1 |
HADS questionnaire measures the presence and severity of anxiety and depression in both hospital and community settings. The questionnaire comprised of 14 items divided into 2 subscales: 7 items for anxiety subscale (HADS-A) and 7 items for depression subscale (HADS-D). Each item was scored on a 0 to 3 rating scale. The anxiety and depression subscales each ranged from 0 to 21 (0-7: normal, 8-10: borderline abnormal and 11-21: abnormal), where higher scores indicated greater severity of anxiety/depression. The subscales were independent for each result of depression and anxiety.
| score on a scale | Sarilumab |
|---|---|
| HADS-A: Week 4 | -1.0 ± 2.4 |
| HADS-A: Week 12 | -2.1 ± 3.3 |
| HADS-A: Week 24 | -1.9 ± 3.2 |
| HADS-D: Week 4 | -0.4 ± 2.5 |
| HADS-D: Week 12 | -1.2 ± 4.1 |
| HADS-D: Week 24 | -1.7 ± 3.7 |
MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a visual analog scale (VAS; in centimeters \[cm\]) ranged from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.
| cm | Sarilumab |
|---|---|
| Baseline | 88.4 ± 21.1 |
| Week 4 | 89.6 ± 20.3 |
| Week 12 | 94.8 ± 13.6 |
| Week 24 | 90.9 ± 22.3 |
MAThyS was a multi-dimensional self-administered questionnaire comprised of five dimensions (emotional reactivity, cognition speed, psychomotor function, motivation and sensory perception) divided into 20 items relating to individual states as perceived by participants for the preceding week (at each specified Week). Each item was measured on a VAS (in cm) ranging from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state). Total MAThyS score was sum of the 20 items and that might vary from score range 0 to 200 with lower scores indicated general inhibition and higher scores indicated general excitation.
| cm | Sarilumab |
|---|---|
| Week 4 | -0.2 ± 24.2 |
| Week 12 | 2.9 ± 17.7 |
| Week 24 | -1.1 ± 23.4 |
FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).
| score on a scale | Sarilumab |
|---|---|
| Baseline | 25.5 ± 10.3 |
| Week 4 | 21.0 ± 10.5 |
| Week 12 | 18.8 ± 9.7 |
| Week 24 | 17.9 ± 11.4 |
FACIT-F was a 13-item questionnaire that assess fatigue in participants under chronic illness therapy. Participants scored each item on a 5-point Likert scale ranged from 0 to 4 (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The scores of each item were reversed during score calculations, so that higher score values indicated more favorable conditions. Total score was the sum of score from each item and resulted in a score range from 0 to 52, with higher score indicated better participant health status (lower level of fatigue).
| score on a scale | Sarilumab |
|---|---|
| Week 4 | -4.8 ± 8.0 |
| Week 12 | -6.4 ± 9.1 |
| Week 24 | -7.6 ± 10.8 |
HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week (at each specified visit) rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.
| score on a scale | Sarilumab |
|---|---|
| Baseline | 1.3 ± 0.8 |
| Week 4 | 1.1 ± 0.7 |
| Week 12 | 0.8 ± 0.7 |
| Week 24 | 0.8 ± 0.8 |
HAQ-DI was a participant-oriented questionnaire developed specifically to assess the extent of a RA participant's functional ability. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week (at each specified visit) rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, and ranged from 0 to 3, where 0 = no disability and 3 = completely disabled, higher score indicated more disability.
| score on a scale | Sarilumab |
|---|---|
| Week 4 | -0.2 ± 0.5 |
| Week 12 | -0.4 ± 0.6 |
| Week 24 | -0.5 ± 0.8 |
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.
| minutes | Sarilumab |
|---|---|
| Baseline | 72.3 ± 75.0 |
| Week 4 | 34.7 ± 43.9 |
| Week 12 | 28.9 ± 47.2 |
| Week 24 | 21.3 ± 37.5 |
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. At each specified time point, duration of morning stiffness was reported by the participant during the visit.
| minutes | Sarilumab |
|---|---|
| Week 4 | -39.9 ± 67.9 |
| Week 12 | -47.9 ± 76.8 |
| Week 24 | -52.8 ± 72.3 |
IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in metabolic equivalent (MET)-minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
| MET minutes per week | Sarilumab |
|---|---|
| Baseline | 1759.9 ± 1185.0 |
| Week 4 | 1881.1 ± 1203.9 |
| Week 12 | 2061.0 ± 1266.9 |
| Week 24 | 2089.5 ± 1476.4 |
IPAQ was a 27-item self-reported questionnaire designed to measure physical activity of participant. The score was reported in MET minutes per week. MET minutes represented the amount of energy expended to carry out physical activity. For IPAQ total score, the minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.
| MET minutes per week | Sarilumab |
|---|---|
| Week 4 | 175.6 ± 1177.7 |
| Week 12 | 533.4 ± 1509.7 |
| Week 24 | 382.0 ± 1719.8 |
PtGA of disease activity was measured using a 100 millimeters (mm) horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.
| mm | Sarilumab |
|---|---|
| Baseline | 61.1 ± 22.4 |
| Week 4 | 44.1 ± 25.6 |
| Week 12 | 36.6 ± 26.7 |
| Week 24 | 34.6 ± 25.6 |
PtGA of disease activity was measured using a 100 mm horizontal VAS ranged from 0=no pain to 100=maximum pain imaginable, where higher score indicated more disease activity.
| mm | Sarilumab |
|---|---|
| Week 4 | -17.2 ± 24.2 |
| Week 12 | -24.3 ± 31.8 |
| Week 24 | -26.7 ± 29.6 |
ESR was a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).
| mm/h | Sarilumab |
|---|---|
| Baseline | 28.8 ± 23.4 |
| Week 4 | 10.5 ± 15.5 |
| Week 12 | 9.2 ± 15.3 |
| Week 24 | 8.4 ± 11.3 |
ESR was a laboratory test to provide non-specific measure of inflammation in the body. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/h.
| mm/h | Sarilumab |
|---|---|
| Week 4 | -18.1 ± 21.1 |
| Week 12 | -19.5 ± 25.1 |
| Week 24 | -22.0 ± 23.2 |
DAS28-ESR was a composite score that included 4 variables: tender joint count (TJC) (based on 28 joints); swollen joint count (SJC) (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score less than or equal to (\<=) 3.2 indicated low disease activity (LDA), greater than (\>) 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
| score on a scale | Sarilumab |
|---|---|
| Baseline | 5.0 ± 1.2 |
| Week 4 | 3.1 ± 1.5 |
| Week 12 | 2.6 ± 1.5 |
| Week 24 | 2.3 ± 1.4 |
DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable); marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score \<= 3.2 indicated LDA, \> 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
| score on a scale | Sarilumab |
|---|---|
| Week 4 | -1.8 ± 1.1 |
| Week 12 | -2.3 ± 1.6 |
| Week 24 | -2.7 ± 1.5 |
CDAI was a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
| score on a scale | Sarilumab |
|---|---|
| Baseline | 22.5 ± 11.2 |
| Week 4 | 12.6 ± 9.8 |
| Week 12 | 9.9 ± 10.4 |
| Week 24 | 8.1 ± 7.8 |
CDAI was a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment of disease (in cm). CDAI total score ranges from 0 to 76 with a lower score indicating less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
| score on a scale | Sarilumab |
|---|---|
| Week 4 | -9.8 ± 8.1 |
| Week 12 | -12.2 ± 13.2 |
| Week 24 | -14.6 ± 12.6 |
Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
| joints | Sarilumab |
|---|---|
| Baseline | 6.3 ± 5.1 |
| Week 4 | 2.5 ± 3.2 |
| Week 12 | 1.9 ± 3.6 |
| Week 24 | 1.6 ± 2.8 |
Number of joints with swelling are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
| joints | Sarilumab |
|---|---|
| Week 4 | -3.9 ± 4.3 |
| Week 12 | -4.1 ± 5.1 |
| Week 24 | -4.7 ± 5.2 |
Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
| joints | Sarilumab |
|---|---|
| Baseline | 7.3 ± 5.8 |
| Week 4 | 4.7 ± 5.4 |
| Week 12 | 3.5 ± 5.2 |
| Week 24 | 2.5 ± 4.1 |
Number of joints with tenderness are reported. Joints which were assessed included 28 joints (which included shoulders, elbows, wrists, knees and 2 joints in each finger and thumb).
| joints | Sarilumab |
|---|---|
| Week 4 | -2.5 ± 4.5 |
| Week 12 | -3.7 ± 6.5 |
| Week 24 | -4.8 ± 6.4 |
DAS28-ESR was a composite score that included 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); participant's global assessment of health activity using 100 mm VAS: range 0 (no pain) to 100 (maximum pain imaginable) marker of inflammation assessed by ESR in mm/h. DAS28-ESR total score ranged from 0-10, higher score indicated more disease activity. The DAS28-ESR score provided a number indicating the current disease activity of the RA. A DAS28-ESR score above 5.1 indicated high disease activity, DAS28-ESR score \<= 3.2 indicated LDA, \> 3.2 to \<=5.1 implied moderate disease activity and DAS28-ESR score below 2.6 indicated disease remission.
| Participants | Sarilumab |
|---|---|
| LDA: Week 12 | 12 |
| LDA: Week 24 | 4 |
| Remission: Week 12 | 40 |
| Remission: Week 24 | 45 |
CDAI was a composite index constructed to measure clinical remission in RA that does not included a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment (in cm). Total score ranged from 0 to 76 with a lower score indicated less disease activity. A CDAI score of \<=2.8 represents clinical remission and a score of \<=10.0 represents LDA.
| Participants | Sarilumab |
|---|---|
| LDA: Week 12 | 29 |
| LDA: Week 24 | 29 |
| Remission: Week 12 | 18 |
| Remission: Week 24 | 20 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the study treatment. SAE: Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that occurred in the time from the first injection of study drug up to 39.7 weeks.
| Participants | Sarilumab |
|---|---|
| SAE | 10 |
| TEAE | 76 |
| AE leading to death | 0 |
Collected over All AEs were collected from the time of first injection of study drug up to 39.7 weeks regardless of seriousness or relationship to study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sarilumab | 0/84 (0%) | 10/84 (11.9%) | 54/84 (64.3%) |
| Event | Sarilumab |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 1/84 |
| Drug HypersensitivityImmune system disorders | 1/84 |
| PneumoniaInfections and infestations | 1/84 |
| Diabetes Mellitus Inadequate ControlMetabolism and nutrition disorders | 1/84 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/84 |
| Back PainMusculoskeletal and connective tissue disorders | 1/84 |
| Lumbar Spinal StenosisMusculoskeletal and connective tissue disorders | 1/84 |
| Rheumatoid ArthritisMusculoskeletal and connective tissue disorders | 1/84 |
| PolyneuropathyNervous system disorders | 1/84 |
| Interstitial Lung DiseaseRespiratory, thoracic and mediastinal disorders | 1/84 |
| Event | Sarilumab |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 16/84 |
| NauseaGastrointestinal disorders | 10/84 |
| BronchitisInfections and infestations | 10/84 |
| AstheniaGeneral disorders | 9/84 |
| FatigueGeneral disorders | 9/84 |
| NasopharyngitisInfections and infestations | 9/84 |
| HeadacheNervous system disorders | 9/84 |
| PruritusSkin and subcutaneous tissue disorders | 6/84 |
| DiarrhoeaGastrointestinal disorders | 5/84 |
| Injection Site ErythemaGeneral disorders | 5/84 |
Analysis was performed on intent-to-treat (ITT) population which included participants who met all the eligibility criteria and received study treatment at least once.
| Age, Continuous(years) | Sarilumab |
|---|---|
| Mean | 59.1 ± 12.3 |
| Sex: Female, Male(Participants) | Sarilumab |
|---|---|
| Female | 63 |
| Male | 21 |
| Race and Ethnicity Not Collected(Participants) | Sarilumab |
|---|
| Rheumatoid Arthritis Impact of Disease (RAID) - Baseline Total Score(score on a scale) | Sarilumab |
|---|---|
| Mean | 5.8 ± 1.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi