Status:
COMPLETED
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
Lead Sponsor:
UCB Pharma SA
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease ...
Eligibility Criteria
Inclusion
- Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
- Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
- Active RA disease
- DMARD-naïve
- Subject is naïve to RA related biologics
Exclusion
- A diagnosis of any other inflammatory Arthritis
- History of infected joint prosthesis, or other significant infection and other serious medical condition
- Known Tuberculosis (TB) disease or high risk of acquiring TB infection
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT01519791
Start Date
January 1 2012
End Date
September 1 2015
Last Update
July 31 2018
Active Locations (178)
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1
209
Birmingham, Alabama, United States
2
170
Huntsville, Alabama, United States
3
180
Mobile, Alabama, United States
4
247
Glendale, Arizona, United States