Status:
COMPLETED
Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Lead Sponsor:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with mod...
Detailed Description
Treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52. In the double blind phase eligible patients will be randomiz...
Eligibility Criteria
Inclusion
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years
Exclusion
- All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00674362
Start Date
June 1 2008
End Date
December 1 2010
Last Update
January 18 2012
Active Locations (31)
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1
Graz, Austria
2
Vienna, Austria
3
Nantes, France
4
Paris, France