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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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4 February 2019 |
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Main ID: |
NCT03700021 |
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Date of registration:
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02/10/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis
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Scientific title:
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Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs |
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Date of first enrolment:
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April 2019 |
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Target sample size:
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25 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03700021 |
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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: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Tania Moin |
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Address:
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Telephone:
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212-263-9440 |
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Email:
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Tania.Moin@nyumc.org |
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Affiliation:
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Name:
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Tania Moin |
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Address:
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Telephone:
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212 263 9440 |
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Email:
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Tania.Moin@nyulangone.org |
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Affiliation:
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Name:
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Gregg Silverman |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men or women (not nursing or pregnant) over 18 years old who have active RA, defined
as symptoms of RA prior to screening and have satisfied the ACR/EULAR 2010 criteria
for the classification of RA prior to signing the informed consent.
- Subjects must have a DAS28CRP and CDAI assessment at screening and have at least 3
tender and at least 3 swollen joints (excluding distal interphalangeal joints) at
screening and at Day 1. Patients must have at least moderate disease activity
{CDAI>16); DAS28CRP (>4.0 )].
- Subjects must be naive to biologic DMARDs
- Subjects must be naive to targeted synthetic DMARDs such as tofacitinib, baricitinib,
and investigational therapies for RA.
- Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent
of 10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or
IA administration of a corticosteroid within 4 weeks prior to screening visit or
initiation of therapy
- Patients with prior (including discontinued) therapy with Methotrexate and/or
Hydroxychloroquine are permitted as long as they meet other inclusionary criteria.
- Subjects must have a DAS28CRP and CDAI at screening and have at least 3 tender and at
least 3 swollen joints (excluding distal interphalangeal joints) at screening and at
Day 1.
Exclusion Criteria:
- Subjects with autoimmune disease other than RA [e.g., psoriasis, systemic lupus
erythematosus (SLE), vasculitis, seronegative spondyloarthritis, Inflammatory Bowel
Disease, Sjogren's syndrome] or currently active fibromyalgia.
- Prior history of or current inflammatory joint disease other than RA (such as
psoriatic arthritis, gout, reactive arthritis, Lyme disease).
Medical History and Concurrent Diseases
- Subjects who are prisoners, or compulsory detained.
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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Drug: Abatacept + csDMARD
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Primary Outcome(s)
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Disease Activity measured using Health Assessment Questionnaire (HAQ)
[Time Frame: 12 Months]
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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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