Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01500278 |
Date of registration:
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22/12/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
Date of first enrolment:
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December 2011 |
Target sample size:
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915 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01500278 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Austria
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Bulgaria
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Canada
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Czech Republic
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Czechia
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Mexico
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Monaco
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Poland
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Portugal
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Romania
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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UCB Cares |
Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by
the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology
(ACR) classification criteria (Aletaha D et al, 2010)
- Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic
Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at
Screening
- Subject must have moderate to severe RA disease at Screening and Baseline defined as:
1. Screening (all criteria required)
- = 4 swollen joints (of 28 prespecified joints)
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
- C-Reactive Protein (CRP) concentration = 10 mg/L (or 1.0 mg/dL) or
Erythrocyte Sedimentation Rate (ESR) (Westergren) = 28 mm/hr
2. Baseline (both criteria required)
- = 4 swollen joints (of 28 prespecified joints)
- Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) > 3.2
- Subject must have inadequately responded previously to Methotrexate (MTX)
- Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has
used the same MTX regimen for a minimum of 28 days prior to Baseline
Exclusion Criteria:
- Subject has previously received any biological Disease Modifying Antirheumatic Drug
(DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase,
phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine
kinase
- Diagnosis of any other inflammatory arthritis
- Infected with Tuberculosis (TB) or high risk of acquiring TB infection
- Subjects with concurrent acute or chronic viral hepatitis B or C infection
- Subjects with a history of chronic or recurrent infections or subjects at high risk of
infection
- Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological
DMARDs excluding study medications, experimental therapy, IA hyaluronic acid
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Biological: Adalimumab (ADA)
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Biological: Certolizumab Pegol (CZP)
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Drug: Methotrexate (MTX)
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Primary Outcome(s)
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Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104
[Time Frame: Week 104]
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Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
[Time Frame: Week 12]
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Secondary Outcome(s)
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Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 12
[Time Frame: Week 12]
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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
[Time Frame: From Baseline to Week 104]
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Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
[Time Frame: From Week 12 up to Week 104]
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Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104
[Time Frame: Week 104]
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Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12
[Time Frame: Week 104]
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Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) = 3.2 at Week 6
[Time Frame: Week 6]
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Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
[Time Frame: Week 6]
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Secondary ID(s)
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RA0077
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2011-002067-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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