CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 194 enrolled
Drug / intervention
Certolizumab pegol +1 morebiological
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/NCT00674362
NCT00674362Phase 3Completed

A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

UCB Pharma·interventional·Posted May 7, 2008·Updated Jan 18, 2012

In Brief

A Phase 3 clinical trial evaluating Certolizumab pegol and Placebo for Rheumatoid Arthritis. Completed, enrolled 194 participants across 31 sites in 5 countries.

Detailed Summary

To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartJun 1, 2008
Primary CompletionMay 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.2 years ago

Interventions

Certolizumab pegolbiological

Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)

Placebobiological

Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)