Status:
COMPLETED
Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis
Lead Sponsor:
UCB Italy s.p.a.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.
Eligibility Criteria
Inclusion
- diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
- positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
- active RA disease
- subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
- subject is naïve to RA related biologics
Exclusion
- a diagnosis of any other inflammatory arthritis
- history of infected joint prosthesis, or other significant infection
- known Tuberculosis (TB) disease or high risk of acquiring TB infection
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01443364
Start Date
December 1 2011
End Date
May 1 2015
Last Update
August 15 2017
Active Locations (18)
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1
11
Bari, Italy
2
08
Catania, Italy
3
10
Ferrara, Italy
4
12
Florence, Italy