N/A
Completed N=3,435
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00234884 ↗Enrolled (actual)
3,435
Serious AEs
22.0%
Results posted
Sep 2011
Primary outcomePrimary: Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) — 6.0; 3.3; 3.1; 3.0 units on a scale
Summary
The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) |
6.0; 3.3; 3.1; 3.0; 3.0; 2.9 | — |
| PRIMARY American College of Rheumatology 20% (ACR20) Response Rate |
80.3; 82.9; 84.5; 84.8; 85.8; 87.9 | — |
| PRIMARY American College of Rheumatology 50% (ACR50) Response Rate |
58.8; 62.9; 66.6; 66.2; 68.3; 70.1 | — |
| PRIMARY American College of Rheumatology 70% (ACR70) Response Rate |
34.9; 40.2; 42.9; 44.1; 47.0; 47.5 | — |
| PRIMARY Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) |
-0.70; -0.72; -0.74; -0.75; -0.76; -0.74 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
- Participants must have been willing to consent to data being collected and provided to Abbott.
Exclusion Criteria
· Participants with contraindications according to the SmPC.
Data sourced from ClinicalTrials.gov (NCT00234884). 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.