Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments certolizumab pegol + methotrexate (mtx), placebo + methotrexate (mtx)
Phase phase 3
Sponsor UCB Pharma SA
Start date January 2012
End date July 2015
Trial size 880 participants
Trial identifier NCT01519791, 2011-001729-25, RA0055 Period 1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
certolizumab pegol + methotrexate (mtx) Cimzia
Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50. The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.
(Placebo Comparator)
placebo + methotrexate (mtx) MTX
2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX. The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8.

Primary Outcomes

Measure
Percentage of subjects in sustained remission at Week 52
time frame: Week 52

Secondary Outcomes

Measure
Percentage of subjects in sustained Low Disease Activity (LDA) at Week 52
time frame: Week 52
Change from Baseline in modified Total Sharp Score (mTSS) to Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects with radiographic non-progression from Baseline to Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in the joint erosion score to Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in the joint narrowing score to Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects meeting the American College of Rheumatology 20% response criteria (ACR20) at Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects meeting the American College of Rheumatology 50% response criteria (ACR50) at Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects meeting the American College of Rheumatology 70% response criteria (ACR70) at Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) remission criteria at Week 52
time frame: Week 52
Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52
time frame: Week 52
Percentage of subjects with Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52
time frame: Week 52
Percentage of subjects with Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52
time frame: Week 52
Percentage of subjects meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) remission criteria simplified for clinical practice at Week 52
time frame: Week 52
Percentage of subjects achieving a good or moderate European League Against Rheumatism (EULAR) response at Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in Clinical Disease Activity Index (CDAI) to Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in Simplified Disease Activity Index (SDAI) to Week 52
time frame: From Baseline (Week 0) to Week 52
Percentage of subjects with a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52
time frame: Week 52
Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52
time frame: From Baseline (Week 0) to Week 52
Change from Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) total score to Week 52
time frame: From Baseline (Week 0) to Week 52
Number of work days missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Number of work days with reduced productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Interference with work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Number of days with no household work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Number of days with reduced household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Number of days with hired outside help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Number of days missed of family/social/leisure activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Interference with household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
time frame: Week 52
Percentage of subjects achieving Low Disease Activity (LDA) at Week 52
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by UCB Pharma.