A Phase 2/3 interventional study of Placebo and Upadacitinib in Rheumatoid Arthritis, sponsored by AbbVie. Completed at 50 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by AbbVie · Phase 2/3, Interventional, and Treatment
This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response.
Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.
This study consisted of a 35-day screening period; a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 248-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).
Participants who met eligibility criteria were randomized in a 3:3:3:1:1:1 ratio to one of six treatment groups:
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 197 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with prior exposure to at most one biological disease-modifying anti-rheumatic drug (bDMARD) may be enrolled (up to 20% of total number of subjects) after the required washout period. Specifically, prior to enrollment:
Exclusion Criteria:
Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive Upadacitinib 7.5 mg once daily for 248 weeks.
Drug: Placebo · Drug: Upadacitinib
Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Drug: Placebo · Drug: Upadacitinib
Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.
Drug: Placebo · Drug: Upadacitinib
Period 1: Participants will receive upadacitinib 7.5 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 7.5 mg once daily for 248 weeks.
Drug: Upadacitinib
Period 1: Participants will receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
Drug: Upadacitinib
Period 1: Participants will receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.
Drug: Upadacitinib
Tablet; Oral
Tablet; Oral
Also known as: ABT-494, RINVOQ™
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline and Week 12
Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time frame: Baseline and Week 12
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
Time frame: Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline and Week 12
Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
Time frame: Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12
Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time frame: Week 12
Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
Time frame: Week 12
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Time frame: Baseline and Week 1
Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12
RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is \> 17, it means high risk and it could warrant referral. A negative change from Baseline indicates improvement.
Time frame: Baseline and Week 12
Change From Baseline in the Severity of Morning Stiffness at Week 12
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
Time frame: Baseline and Week 12
Participants with active rheumatoid arthritis (RA) and an inadequate response to conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs) were enrolled at 49 sites in Japan. The study is currently ongoing, results are reported up to Week 60, as of the data cutoff date of 12 July 2018.
| Milestone | Period 1: Placebo | Period 1: Upadacitinib 7.5 mg | Period 1: Upadacitinib 15 mg | Period 1: Upadacitinib 30 mg | Period 2: Upadacitinib 7.5 mg | Period 2: Upadacitinib 15 mg | Period 2: Upadacitinib 30 mg |
|---|---|---|---|---|---|---|---|
| Started | 49 | 49 | 49 | 50 | 0 | 0 | 0 |
| Completed | 47 | 49 | 47 | 44 | 0 | 0 | 0 |
| Not completed | 2 | 0 | 2 | 6 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 5 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Other | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Milestone | Period 1: Placebo | Period 1: Upadacitinib 7.5 mg | Period 1: Upadacitinib 15 mg | Period 1: Upadacitinib 30 mg | Period 2: Upadacitinib 7.5 mg | Period 2: Upadacitinib 15 mg | Period 2: Upadacitinib 30 mg |
|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 65 | 62 | 60 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 65 | 62 | 60 |
| Withdrew: Ongoing | 0 | 0 | 0 | 0 | 57 | 54 | 45 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 4 | 7 | 11 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 2 | 1 | 1 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 2 | 0 | 3 |
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 | 42.9 (29.0 to 56.7) | 75.5 (63.5 to 87.6) | 83.7 (73.3 to 94.0) | 80.0 (68.9 to 91.1) |
The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12 | -0.79 (-1.158 to -0.426) | -2.08 (-2.430 to -1.727) | -2.39 (-2.735 to -2.043) | -2.41 (-2.776 to -2.050) |
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | -0.10 (-0.245 to 0.043) | -0.41 (-0.545 to -0.267) | -0.45 (-0.583 to -0.309) | -0.49 (-0.636 to -0.347) |
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 | 16.3 (6.0 to 26.7) | 40.8 (27.1 to 54.6) | 65.3 (52.0 to 78.6) | 58.0 (44.3 to 71.7) |
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 | 2.0 (0.0 to 6.0) | 20.4 (9.1 to 31.7) | 34.7 (21.4 to 48.0) | 28.0 (15.6 to 40.4) |
The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 | 2.88 (1.03 to 4.72) | 7.21 (5.43 to 8.99) | 6.38 (4.60 to 8.15) | 8.81 (6.93 to 10.68) |
Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 | 18.4 (7.5 to 29.2) | 53.1 (39.1 to 67.0) | 69.4 (56.5 to 82.3) | 72.0 (59.6 to 84.4) |
Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 | 6.1 (0.0 to 12.8) | 36.7 (23.2 to 50.2) | 57.1 (43.3 to 71.0) | 50.0 (36.1 to 63.9) |
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
| percentage of participants | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1 | 8.2 (0.5 to 15.8) | 30.6 (17.7 to 43.5) | 24.5 (12.4 to 36.5) | 34.0 (20.9 to 47.1) |
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12 | 1.81 (-0.35 to 3.97) | 4.47 (2.38 to 6.55) | 3.60 (1.53 to 5.68) | 2.66 (0.48 to 4.85) |
RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is \> 17, it means high risk and it could warrant referral. A negative change from Baseline indicates improvement.
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12 | -0.69 (-2.58 to 1.21) | -3.22 (-5.09 to -1.36) | -2.74 (-4.75 to -0.74) | -2.24 (-4.40 to -0.09) |
Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).
| scores on a scale | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|---|
| Change From Baseline in the Severity of Morning Stiffness at Week 12 | -1.02 (-1.65 to -0.39) | -2.83 (-3.44 to -2.22) | -2.84 (-3.45 to -2.23) | -2.98 (-3.62 to -2.34) |
Collected over Period 1: Weeks 1 to 12; Period 2: Weeks 12 to 60. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1: Placebo | 0/49 (0%) | 0/49 (0%) | 11/49 (22.4%) |
| Period 1: Upadacitinib 7.5 mg | 0/49 (0%) | 1/49 (2%) | 20/49 (40.8%) |
| Period 1: Upadacitinib 15 mg | 0/49 (0%) | 1/49 (2%) | 15/49 (30.6%) |
| Period 1: Upadacitinib 30 mg | 0/50 (0%) | 5/50 (10%) | 27/50 (54%) |
| Period 1+2: Upadacitinib 7.5 mg | 0/65 (0%) | 9/65 (13.8%) | 55/65 (84.6%) |
| Period 1+2: Upadacitinib 15 mg | 0/64 (0%) | 14/64 (21.9%) | 55/64 (85.9%) |
| Period 1+2: Upadacitinib 30 mg | 2/66 (3%) | 18/66 (27.3%) | 60/66 (90.9%) |
| Event | Period 1: Placebo | Period 1: Upadacitinib 7.5 mg | Period 1: Upadacitinib 15 mg | Period 1: Upadacitinib 30 mg | Period 1+2: Upadacitinib 7.5 mg | Period 1+2: Upadacitinib 15 mg | Period 1+2: Upadacitinib 30 mg |
|---|---|---|---|---|---|---|---|
| Pneumocystis jirovecii pneumoniaInfections and infestations | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 0/64 | 4/66 |
| Herpes zosterInfections and infestations | 0/49 | 0/49 | 0/49 | 1/50 | 2/65 | 1/64 | 3/66 |
| PneumoniaInfections and infestations | 0/49 | 0/49 | 0/49 | 0/50 | 1/65 | 0/64 | 2/66 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 0/64 | 2/66 |
| CellulitisInfections and infestations | 0/49 | 0/49 | 1/49 | 0/50 | 0/65 | 1/64 | 0/66 |
| Transient ischaemic attackNervous system disorders | 0/49 | 1/49 | 0/49 | 0/50 | 1/65 | 0/64 | 0/66 |
| Hand-foot-and-mouth diseaseInfections and infestations | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 0/64 | 1/66 |
| Tendon ruptureInjury, poisoning and procedural complications | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 0/64 | 1/66 |
| EncephalopathyNervous system disorders | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 0/64 | 1/66 |
| Sudden hearing lossEar and labyrinth disorders | 0/49 | 0/49 | 0/49 | 0/50 | 0/65 | 1/64 | 0/66 |
| Event | Period 1: Placebo | Period 1: Upadacitinib 7.5 mg | Period 1: Upadacitinib 15 mg | Period 1: Upadacitinib 30 mg | Period 1+2: Upadacitinib 7.5 mg | Period 1+2: Upadacitinib 15 mg | Period 1+2: Upadacitinib 30 mg |
|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 5/49 | 5/49 | 6/49 | 9/50 | 35/65 | 35/64 | 29/66 |
| StomatitisGastrointestinal disorders | 3/49 | 3/49 | 1/49 | 0/50 | 13/65 | 6/64 | 5/66 |
| ConstipationGastrointestinal disorders | 0/49 | 0/49 | 2/49 | 2/50 | 2/65 | 6/64 | 10/66 |
| Herpes zosterInfections and infestations | 1/49 | 1/49 | 0/49 | 2/50 | 5/65 | 9/64 | 10/66 |
| InfluenzaInfections and infestations | 2/49 | 0/49 | 0/49 | 0/50 | 8/65 | 9/64 | 6/66 |
| NauseaGastrointestinal disorders | 0/49 | 0/49 | 0/49 | 3/50 | 8/65 | 2/64 | 7/66 |
| HypertensionVascular disorders | 0/49 | 3/49 | 0/49 | 0/50 | 8/65 | 2/64 | 4/66 |
| Blood creatine phosphokinase increasedInvestigations | 0/49 | 0/49 | 1/49 | 3/50 | 3/65 | 7/64 | 8/66 |
| BronchitisInfections and infestations | 0/49 | 1/49 | 1/49 | 1/50 | 7/65 | 4/64 | 4/66 |
| Tinea pedisInfections and infestations | 0/49 | 0/49 | 0/49 | 1/50 | 0/65 | 4/64 | 7/66 |
The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Mean | 54.3 ± 13.04 | 55.8 ± 11.02 | 56.0 ± 12.50 | 54.7 ± 12.22 | 55.2 ± 12.14 |
| Age, Customized(Participants) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| < 40 years | 7 | 5 | 8 | 3 | 23 |
| 45 to < 65 years | 31 | 32 | 30 | 34 | 127 |
| ≥ 65 years | 11 | 12 | 11 | 13 | 47 |
| Sex: Female, Male(Participants) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Female | 42 | 34 | 36 | 43 | 155 |
| Male | 7 | 15 | 13 | 7 | 42 |
| Race/Ethnicity, Customized(Participants) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Japanese | 49 | 49 | 49 | 50 | 197 |
| Duration of RA Diagnosis(years) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Mean | 4.8 ± 4.86 | 6.7 ± 7.15 | 5.9 ± 7.20 | 4.5 ± 4.30 | 5.5 ± 6.03 |
| Prior Biological Disease-modifying Anti-rheumatic Drug (bDMARD) Use(Participants) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Yes | 3 | 5 | 6 | 3 | 17 |
| No | 46 | 44 | 43 | 47 | 180 |
| Tender Joint Count(joints) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Mean | 16.8 ± 11.42 | 16.3 ± 8.89 | 17.8 ± 12.58 | 16.3 ± 10.79 | 16.8 ± 10.93 |
| Swollen Joint Count(joints) | Placebo | Upadacitinib 7.5 mg | Upadacitinib 15 mg | Upadacitinib 30 mg | Total |
|---|---|---|---|---|---|
| Mean | 10.9 ± 4.65 | 11.7 ± 4.89 | 14.0 ± 7.82 | 11.7 ± 5.32 | 12.1 ± 5.88 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie