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
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/2/2018 |
Start Date: | January 2012 |
End Date: | September 2015 |
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis
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.
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.
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
We found this trial at
67
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