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Health Condition(s) or Problem
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Rheumatoid Arthritis
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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; Cimzia; CZP; MTX; 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; MTX
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Primary aim
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Percentage of subjects in sustained remission at Week 52
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Secondary Aim
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Percentage of subjects in sustained Low Disease Activity (LDA) at Week 52; Week 52; No; Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) = 3.2 at both Weeks 40 and 52.; Change from Baseline in modified Total Sharp Score (mTSS) to Week 52; From Baseline (Week 0) to Week 52; No; Van der Heijde modified Total Sharp Score (mTSS).; Percentage of subjects with radiographic non-progression from Baseline to Week 52; From Baseline (Week 0) to Week 52; No; Radiographic non-progression is defined as change in mTSS = 0.5.; Change from Baseline in the joint erosion score to Week 52; From Baseline (Week 0) to Week 52; No; Change from Baseline in the joint narrowing score to Week 52; From Baseline (Week 0) to Week 52; No; Percentage of subjects meeting the American College of Rheumatology 20% response criteria (ACR20) at Week 52; From Baseline (Week 0) to Week 52; No; The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20% or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).; Percentage of subjects meeting the American College of Rheumatology 50% response criteria (ACR50) at Week 52; From Baseline (Week 0) to Week 52; No; The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).; Percentage of subjects meeting the American College of Rheumatology 70% response criteria (ACR70) at Week 52; From Baseline (Week 0) to Week 52; No; The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).; Percentage of subjects meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) remission criteria at Week 52; Week 52; No; The ACR/EULAR 2011 remission criteria is defined as:
Tender Joint Count (TJC) = 1, Swollen Joint Count (SJC) = 1, C-reactive protein (CRP) = 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) = 1.; Percentage of subjects with Clinical Disease Activity Index (CDAI) = 2.8 at Week 52; Week 52; No; Percentage of subjects with Simplified Disease Activity Index (SDAI) = 3.3 at Week 52; Week 52; No; Percentage of subjects with Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52; Week 52; No; 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; No; The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:
Tender Joint Count (TJC) = 1, Swollen Joint Count (SJC) = 1 and Patient's Global Assessment of Disease Activity (PtGADA) = 1.; Percentage of subjects achieving a good or moderate Europea
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Bury St Edmunds, Cannock, Dudley, Leeds, London, Sheffield, York
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