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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

NCT01521923

CompletedPhase 3

Sponsor: UCB Pharma

Conditions: Rheumatoid Arthritis

Interventions: Certolizumab Pegol + Methotrexate (MTX), Placebo + Methotrexate (MTX)

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 sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

\- Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

Exclusion Criteria:

\- Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28\[ESR\] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
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