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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 in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
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

NCT01519791

CompletedPhase 3

Sponsor: UCB Pharma SA

Conditions: Rheumatoid Arthritis

Interventions: Certolizumab Pegol, Placebo, Methotrexate

Countries: United States, Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (178)
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Glendale, Arizona, United States
  • Paradise Valley, Arizona, United States
  • Paradise Valley, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Covina, California, United States
  • Hemet, California, United States
  • Los Angeles, California, United States
  • San Leandro, California, United States
  • Upland, California, United States
  • Whittier, California, United States
  • Fort Lauderdale, Florida, United States
  • Jupiter, Florida, United States
  • Lake Mary, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Ocala, Florida, United States
  • Orange Park, Florida, United States
  • Orlando, Florida, United States
  • Palm Harbor, Florida, United States
  • Plantation, Florida, United States
  • Sarasota, Florida, United States
  • Vero Beach, Florida, United States
  • Coeur d'Alene, Idaho, United States
  • Springfield, Illinois, United States
  • South Bend, Indiana, United States
  • Cedar Rapids, Iowa, United States
  • + 148 more on CT.gov