Phase 3
Completed N=846
Long Term Open Label Continuation Study
Source: ClinicalTrials.gov NCT00195650 ↗Enrolled (actual)
846
Serious AEs
51.1%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 — 187 participants
Summary
The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 |
187 | — |
| PRIMARY Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 |
402 | — |
| PRIMARY Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 |
132 | — |
| PRIMARY Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 |
279 | — |
| PRIMARY Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 |
78 | — |
| PRIMARY Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 |
179 | — |
| PRIMARY Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520 |
135 | — |
| PRIMARY Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260 |
243 | — |
| PRIMARY Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520 |
-0.52 | — |
| PRIMARY Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260 |
-0.59 | — |
| SECONDARY Reported Adverse Events |
808 | — |
Eligibility Criteria
Inclusion Criteria
- Participant was in a prior D2E7 (adalimumab) study
- Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
Exclusion Criteria
- Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
- Participant had any ongoing chronic or active infection
Data sourced from ClinicalTrials.gov (NCT00195650). 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.