Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis



Status:Not yet recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:April 2019
End Date:November 2019
Contact:Tania Moin
Email:Tania.Moin@nyulangone.org
Phone:212 263 9440

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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

The immune system of patients with Rheumatoid Arthritis (RA) is different from that of people
who do not have RA. The purpose of this study is to examine immune cells and proteins before
subjects start to take study medication and after subjects start treatment with an approved
therapy for RA, abatacept that will be given in combination with Methotrexate and/or
anti-rheumatic drugs (DMARDS) that are approved for the treatment of RA. This study will
assess whether subjects have clinically responded to these medications. This assessment will
also include a study of whether characteristics of the subject's immune system were changed
by therapy with the study drug, abatacept.


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.
We found this trial at
1
site
333 East 38th Street
New York, New York 10016
Principal Investigator: Greg Silverman, MD
Phone: 212-263-9440
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mi
from
New York, NY
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