A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:January 2012
End Date:September 2015

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A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in
combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055
Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low
Disease Activity at Week 52 in study RA0055 Period 1.


Inclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as
DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Exclusion Criteria:

- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as
DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
We found this trial at
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