N/A
Completed N=220
Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))
Source: ClinicalTrials.gov NCT01163292 ↗Enrolled (actual)
220
Serious AEs
3.6%
Results posted
Dec 2013
Primary outcomePrimary: Disease Activity Score (DAS28) — 2.93; 2.73; 2.72; 3.17 units on a scale — p=0.144
Summary
The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Activity Score (DAS28) |
2.93; 2.73; 2.72; 3.17; 2.70; 3.20 | 0.144 |
| SECONDARY Matrix Metalloprotease-3 (MMP-3) |
36; 30; 57; 66; 34; 35 | 0.290 |
| SECONDARY Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 |
0.8; 0.6 | 0.335 |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) |
0.27; 0.24; 0.20; 0.24; 0.20; 0.26 | 0.266 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
51; 39 | — |
Eligibility Criteria
Inclusion Criteria
- The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.
Exclusion Criteria
- Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Data sourced from ClinicalTrials.gov (NCT01163292). 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.