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

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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.


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
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