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 DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.
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)
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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