NCT01500278

Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 915 (actual)
• Sponsor: UCB Pharma SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Certolizumab Pegol (CZP)	* Active substance: an injectable volume of 1 ml solution for injection CZP * Pharmaceutical form: prefilled syringes CZP * Concentration: 200 mg/ml CZP * Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal.
BIOLOGICAL	Adalimumab (ADA)	* Active substance: an injectable volume of 0.8 ml solution for injection ADA * Pharmaceutical form: prefilled syringes ADA * Concentration: 40 mg/0.8 ml ADA * Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal.
DRUG	Methotrexate (MTX)	* Active substance: Methotrexate * Pharmaceutical form: oral tablet * Concentration: 15-25 mg/week * Route of Administration: MTX orally

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2011-12-28
• Last updated: 2018-07-31
• Results posted: 2017-03-31

Locations

175 sites across 20 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Monaco, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom