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Completed
NCT01519791
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
Conditions: Rheumatoid Arthritis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 880
Sponsor: UCB Pharma SA
Location: 209 Birmingham Alabama
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 Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT01519791). StuddyBuddy aggregates publicly available trial information.