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Trial record 11 of 133 for:    Drug | "Connective Tissue Disease" | "Abatacept"

Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03700021
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept + csDMARD Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Experimental: 6 Month Low Disease Activity
In patients who have achieved low disease activity by DAS28-CRP (<3.2) or CDAI(<10), Abatacept will be held for 6 months or until a flare results.
Drug: Abatacept + csDMARD
Abatacept Time 0, Week 2, Month1,2,3, 4, & 5 IV administration on Abatacept (7 infusions). Abatacept will be initiated in concert with methotrexate or pre-existing csDMARD.

Experimental: Patints with Flare at 6 Months
DAS28-CRP that is greater than an absolute value of 4.0) or a CDAI >15
Drug: Abatacept + csDMARD
Abatacept Time 0, Week 2, Month1,2,3, 4, & 5 IV administration on Abatacept (7 infusions). Abatacept will be initiated in concert with methotrexate or pre-existing csDMARD.




Primary Outcome Measures :
  1. Disease Activity measured using Health Assessment Questionnaire (HAQ) [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700021


Contacts
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Contact: Tania Moin 212 263 9440 Tania.Moin@nyulangone.org

Locations
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United States, New York
New York University Langone Health Not yet recruiting
New York, New York, United States, 10016
Contact: Tania Moin    212-263-9440    Tania.Moin@nyumc.org   
Principal Investigator: Greg Silverman, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Gregg Silverman NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03700021     History of Changes
Other Study ID Numbers: 18-01164
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors