CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 285 enrolled
Drug / intervention
Certolizumab pegol +1 moredrug
Likely dose
Methotrexate 8 mgfrom 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.

Search/NCT00851318
NCT00851318Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)

Astellas Pharma Inc·interventional·Posted Feb 25, 2009·Updated Nov 3, 2014

In Brief

A Phase 3 clinical trial evaluating Certolizumab pegol and Methotrexate for Rheumatoid Arthritis. Completed, enrolled 285 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
CollaboratorsUCB Japan Co. Ltd.

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.4 years ago

Interventions

Certolizumab pegoldrug

Subcutaneous (SC) injection

Methotrexatedrug

Methotrexate dose between 6 to 8 mg/week.