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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Rheumatoid Arthritis
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : Certolizumab Pegol + Methotrexate (MTX), Biological : Placebo + Methotrexate (MTX)

Study Arm Groups : Certolizumab Pegol + Methotrexate, Placebo + Methotrexate

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
London
Leeds
England
Sheffield
York
Cannock
Guest Hospital
Dudley
West Midlands
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
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
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
RA0055 Period 1
Sponsor(s)
UCB Pharma SA
Key Dates

Recruitment Start Date

Jan 2012

Recruitment End Date

Jul 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

19 Jan 2012

Last Updated

13 May 2015