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 |
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.
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.
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
We found this trial at
102
sites
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