NCT01521923

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 for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol + Methotrexate (MTX)	Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml. On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W). CZP and PBO administration to be staggered 2 Weeks apart to maintain blind. The MTX treatment is to remain between 15-25 mg/week.
BIOLOGICAL	Placebo + Methotrexate (MTX)	1 syringe of Placebo every 2 Weeks and MTX. The MTX treatment is to remain between 15-25 mg/week.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2012-01-31
• Last updated: 2018-07-31
• Results posted: 2017-01-10

Locations

178 sites across 22 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Italy, Mexico, Monaco, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom