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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03789292 |
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Date of registration:
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27/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
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Scientific title:
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A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis |
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Date of first enrolment:
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November 26, 2018 |
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Target sample size:
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564 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03789292 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient is male or female aged 18 to 75 years old, both inclusive.
- Patient has had a diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR
classification criteria for at least 24 weeks prior to the first administration of the
study drug .
Exclusion Criteria:
- Patient who has previously received investigational or licensed product; biologic or
targeted synthetic disease-modifying antirheumatic drugs for the treatment of
rheumatoid arthritis and/or a tumor necrosis factor (TNF) a inhibitor for any
purposes.
- Patient who has allergies to any of the excipients of study drug or any other murine
and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Age minimum:
18 Years
Age maximum:
75 Years
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: Humira SC
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Biological: CT-P17 SC
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Primary Outcome(s)
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Clinical response according to the ACR definition of a 20% improvement (ACR20)
[Time Frame: Week 24]
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Secondary ID(s)
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CT-P17 3.1
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2018-001690-25
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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