Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:July 2008
End Date:March 2011

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A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab
pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized
period followed by an open-label extension phase. In the double-blind phase, eligible
patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up
to and including Week 10. The randomization will be stratified according to the three
factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor
(anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From
Week 12 all patients remaining in the study receive open-label CZP for a minimum 16
additional weeks until CZP is commercially available.

Inclusion Criteria:

- Adult patient with established moderate to severe rheumatoid arthritis

Exclusion Criteria:

- All concomitant diseases or pathological conditions that could interfere and impact
the assessment of the study treatment

- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trials
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