Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having
met the pre-defined criteria for flare (defined as patients that have randomized at Week 18
and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to
Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll
in C87084 and receive certolizumab pegol [400 mg at Entry, Week 2, and Week 4 followed by 200
mg every two weeks (Q2W)] in combination with MTX until the drug is commercially available
for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until
further notice from UCB.
All patients will continue their MTX treatment at the same stable dose as during the C87077
(NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.
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