Phase 3
Completed N=285
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Source: ClinicalTrials.gov NCT00851318 ↗Enrolled (actual)
285
Serious AEs
23.9%
Results posted
Sep 2014
Primary outcomePrimary: Number of Participants With Adverse Events — 77; 18; 92; 90 participants
Summary
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), 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 275-08-001.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
77; 18; 92; 90; 20; 4 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% (ACR20) Response |
71.6; 68.4; 96.8; 98.9; 76.5; 84.2 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% (ACR50) Response |
42.0; 36.8; 83.9; 82.6; 48.1; 57.9 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70% (ACR70) Response |
14.8; 26.3; 60.2; 47.8; 30.9; 31.6 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS) 28 |
-2.28; -2.32; -3.24; -3.23; -2.65; -2.34 | — |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) |
1.48; 1.69; 0.71; 0.08; 5.13; 4.97 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who participated in Study 275-08-001 and meet all of the criteria described below.
- Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week 24.
- Patients who are able to receive treatment with MTX, by Week 52.
Exclusion Criteria
- Patients who experienced an important protocol deviation as mentioned below during Study 275-08-001.
- Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).
- Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-001.
- Patients who required treatment for the same infection at two or more different times during Study 275-08-001
- 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 (NCT00851318). 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.