Phase 3
Completed N=334
A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00870467 ↗Enrolled (actual)
334
Serious AEs
4.9%
Results posted
Apr 2012
Primary outcomePrimary: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 — 1.5; 2.4 units on a scale — p=<0.001
Summary
To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 |
1.5; 2.4 | <0.001 sig |
| SECONDARY Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology) |
129; 92 | <0.001 sig |
| SECONDARY Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology) |
110; 63 | <0.001 sig |
| SECONDARY Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology) |
81; 37 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26 |
-2.8; -1.8 | <0.001 sig |
| SECONDARY Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26 |
52; 24 | <0.001 sig |
| SECONDARY Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26 |
138; 117 | — |
| SECONDARY Change From Baseline in Modified Total Sharp X-Ray Score at Week 52 |
1.6; 2.1; 9.6; 6.8 | — |
| SECONDARY Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology) |
129; 113; 4; 21 | — |
| SECONDARY Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology) |
117; 101; 2; 15 | — |
| SECONDARY Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology) |
87; 85; 0; 10 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52 |
-3.7; -3.7; -1.9; -3.4 | — |
| SECONDARY Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52 |
62; 55; 0; 4 | — |
| SECONDARY Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52 |
289 | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis based on the American College of Rheumatology criteria
- Methotrexate or leflunomide naïve
- Disease duration less than or equal to 2 years from diagnosis
Exclusion Criteria
- History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
- Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Data sourced from ClinicalTrials.gov (NCT00870467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.