CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Certolizumab Pegolbiological
Likely dose
Certolizumab Pegol 200 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/NCT00843778
NCT00843778Phase 3Completed

A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.

UCB Pharma·interventional·Posted Feb 13, 2009·Updated Jan 30, 2014

In Brief

A Phase 3 clinical trial evaluating Certolizumab Pegol for Rheumatoid Arthritis. Completed, enrolled 131 participants across 25 sites in 5 countries.

Detailed Summary

To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany, Italy, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 13, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.4 years ago

Interventions

Certolizumab Pegolbiological

200 mg every two weeks Certolizuimab Pegol 200 mg every two weeks Subjects who flared at Week 48 or Week 52 of feeder study C87076 \[NCT00674362\], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.