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 | Not Recruiting
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
C-early
Trial Source

Health Conditions
  • Rheumatoid Arthritis
Not Recruiting
Recruitment Status
NCT01519791
Primary Trial ID Number
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.
Primary Outcome Measures
  • Percentage of subjects in sustained remission at Week 52; Week 52
Secondary Outcome Measures
  • Percentage of subjects in sustained Low Disease Activity (LDA) at Week 52; Week 52; Change from Baseline in modified Total Sharp Score (mTSS) to Week 52; From Baseline (Week 0) to Week 52; Percentage of subjects with radiographic non-progression from Baseline to Week 52; From Baseline (Week 0) to Week 52; Change from Baseline in the joint erosion score to Week 52; From Baseline (Week 0) to Week 52; Change from Baseline in the joint narrowing score to Week 52; From Baseline (Week 0) to Week 52; Percentage of subjects meeting the American College of Rheumatology 20% response criteria (ACR20) at Week 52; From Baseline (Week 0) to Week 52; Percentage of subjects meeting the American College of Rheumatology 50% response criteria (ACR50) at Week 52; From Baseline (Week 0) to Week 52; Percentage of subjects meeting the American College of Rheumatology 70% response criteria (ACR70) at Week 52; 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; Week 52; Percentage of subjects with Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52; Week 52; Percentage of subjects with Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52; Week 52; Percentage of subjects with Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52; 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; Week 52; Percentage of subjects achieving a good or moderate European League Against Rheumatism (EULAR) response at Week 52; From Baseline (Week 0) to Week 52; Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52; From Baseline (Week 0) to Week 52; Change from Baseline in Clinical Disease Activity Index (CDAI) to Week 52; From Baseline (Week 0) to Week 52; Change from Baseline in Simplified Disease Activity Index (SDAI) to Week 52; From Baseline (Week 0) to Week 52; Percentage of subjects with a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52; Week 52; Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52; 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; From Baseline (Week 0) to Week 52; Number of work days missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Number of work days with reduced productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Interference with work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Number of days with no household work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Number of days with reduced household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Number of days with hired outside help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Number of days missed of family/social/leisure activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Interference with household work productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52; Week 52; Percentage of subjects achieving Low Disease Activity (LDA) at Week 52; Week 52
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Argentina; Australia; Austria; Belgium; Canada; Colombia; Czech Republic; France; Germany; Hungary; Ireland; Italy; Mexico; Monaco; Netherlands; Poland; Romania; Spain; Sweden; Switzerland; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion 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
Interventions
Biological; Certolizumab Pegol + Methotrexate (MTX); 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.; [Certolizumab Pegol + Methotrexate]; Biological; Placebo + Methotrexate (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.; [Placebo + Methotrexate]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
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Acronym
C-early
Scientific 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
Secondary Trial Identifying Number
2011-001729-25
Website
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Study Funded By
UCB Pharma SA
Funder Type
Sorry, this information is not available
Study Sponsored By
UCB Pharma SA
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
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Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

19 Jan 2012

Last Updated

13 May 2015

Date Record Refreshed on UKCTG

31 Jul 2015