NCT00843778

Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 \[NCT00674362\] designed to continue to assess the safety and efficacy of Certolizumab Pegol. Two different population will enter the study from C87076 \[NCT00674362\] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB: Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 \[NCT00674362\].The Week 24 assessment (visit 14) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 \[NCT00674362\]. Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 \[NCT00674362\]. The Week 52 assessment (visit 26) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. Subjects who flared prior to Week 48 in the C87076 \[NCT00674362\] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study. Those who flared at Week 48 or Week 52, 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-02-13
• Last updated: 2014-01-30
• Results posted: 2013-10-31

Locations

25 sites across 5 countries: Austria, France, Germany, Italy, Poland