Phase 3
Completed N=208
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Source: ClinicalTrials.gov NCT00850343 ↗Enrolled (actual)
208
Serious AEs
36.5%
Results posted
Sep 2014
Primary outcomePrimary: Number of Participants With Adverse Events — 102; 12; 41; 40 participants
Summary
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
102; 12; 41; 40; 16; 4 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% (ACR20) Response |
60.9; 58.3; 90.7; 90.7; 70.0; 83.3 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% (ACR50) Response |
29.1; 41.7; 69.8; 74.4; 40.9; 58.3 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% (ACR70) Response |
14.5; 16.7; 46.5; 48.8; 22.7; 16.7 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS) 28 |
-1.87; -2.46; -3.10; -2.87; -2.15; -2.53 | — |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) |
1.48; 2.18; 0.77; -0.05; 7.89; 8.73 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who participated in Study 275-08-003 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.
Exclusion Criteria
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
- Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-003
- Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
- Patients whom the investigator has decided to be inappropriate for participation in the study
Data sourced from ClinicalTrials.gov (NCT00850343). 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.