N/A
Completed N=172
Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069
Source: ClinicalTrials.gov NCT01346501 ↗Enrolled (actual)
172
Serious AEs
4.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment — 100.0; 77.9; 71.4; 63.6 Percentage of participants
Summary
The main objective of this study was to determine the ability to maintain response after discontinuation of adalimumab treatment and the secondary objective was to determine radiographic progression in participants participating in the study, including the percentage who displayed minimal progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment |
100.0; 77.9; 71.4; 63.6; 58.4; 54.5 | — |
| PRIMARY Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3) |
79.2; 67.9; 53.2; 38.6; 37.7; 27.4 | — |
| PRIMARY Mean Health Assessment Questionnaire (HAQ) Score |
1.19; 1.04; 0.48; 0.42; 0.27; 0.25 | — |
| SECONDARY Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5 |
66.2; 55.7; 83.1; 67.2 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions |
16; 2; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
Participants with RA who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.
Exclusion Criteria
Participants with RA who used biological agents other than adalimumab in the one year observational period of study P12-069.
Data sourced from ClinicalTrials.gov (NCT01346501). 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.