At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
Certolizumab pegoldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003)
In Brief
A Phase 3 clinical trial evaluating Certolizumab pegol for Rheumatoid Arthritis. Completed, enrolled 208 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsUCB Japan Co. Ltd.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionMay 2013
TodayJul 2026
First PostedFeb 25, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.4 years ago
Interventions
Certolizumab pegoldrug
Subcutaneous (SC) injection