Phase 3
Completed N=302
Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate
Source: ClinicalTrials.gov NCT00538902 ↗Enrolled (actual)
302
Serious AEs
4.3%
Results posted
Dec 2009
Primary outcomePrimary: Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period — 21; 69; 62 Participants — p=0.026
Summary
A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period |
21; 69; 62 | 0.026 sig |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period |
9; 39; 29; 2; 19; 11 | 0.009 sig |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period |
152; 179; 183; 207; 153; 158 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period |
77; 95; 103; 119; 96; 102 | — |
| SECONDARY Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period |
32; 39; 49; 52; 39; 48 | — |
| SECONDARY Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period |
-7.0; -12.2; -8.8; -4.7; -8.6; -6.4 | — |
| SECONDARY Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period |
22.8; -9.9; -12.3; -13.4; -14.4; -16.4 | — |
| SECONDARY Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period |
11.2; -6.9; -7.4; -8.3; -8.8; -9.3 | — |
| SECONDARY Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period |
-20.6; -25.1; -20.9; -14.9; -22.7; -16.4 | — |
| SECONDARY Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period |
60.1; -22.8; -25.5; -28.3; -31.3; -30.7 | — |
| SECONDARY Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period |
60.5; -18.7; -21.1; -23.3; -27.1; -25.4 | — |
| SECONDARY Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period |
60.7; -19.0; -21.0; -23.6; -26.3; -26.6 | — |
| SECONDARY Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period |
-0.3; -0.5; -0.4 | — |
| SECONDARY Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period |
1.38; -0.42; -0.51; -0.55; -0.61; -0.56 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period |
4.2; 5.7; 4.5; 3.5; 4.9; 2.5 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period |
32.14; 5.01; 7.15; 6.8; 7.96; 8.17 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period |
36.50; 3.74; 5.73; 5.22; 5.51; 5.29 | — |
Eligibility Criteria
Inclusion Criteria
- Met ACR criteria for diagnosis of active rheumatoid arthritis (RA) and have had at both the Screening visit and Week 0 visit at least four swollen joints (out of 66 assessed) and at least six tender joints(out of 68 assessed)
- Subjects must have failed prior treatment with one or more disease-modifying antirheumatic drugs (DMARDs)
- DMARDs (other than methotrexate [MTX]) must have been discontinued for >= 28 days or at least 5 half-lives, whichever is greater, before the Week 0 visit
- Traditional Chinese Medicines must have been discontinued for >= 28 days before the Week 0 visit
- Subjects must have received at least three months of treatment with MTX (minimum 7.5 mg/week) and remained on a stable dose of MTX for >= 28 days prior to the Screening visit
- Glucocorticoids equivalent to <= 10 mg of prednisone and prednisone equivalent must have remained unchanged for at least 28 days prior to the Week 0 visit
- Must have been able and willing to give written informed consent and to comply with the requirements of this study protocol
Exclusion Criteria
- A history of, or current, acute inflammatory joint disease of different origin (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, fibromyalgia or any arthritide with onset prior to age 16 years
- Wheelchair-bound or bedridden
- Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit
- Intra-articular, intramuscular or intravenous administration of corticosteroids within 28 days prior to the Screening visit
- Prior treatment with any TNF antagonist, including adalimumab
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Data sourced from ClinicalTrials.gov (NCT00538902). 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.