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Trial record 11 of 134 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

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date January 25, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
Disease Activity measured using Health Assessment Questionnaire (HAQ) [ Time Frame: 12 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03700021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Abatacept + csDMARD
  • Experimental: Patints with Flare at 6 Months
    DAS28-CRP that is greater than an absolute value of 4.0) or a CDAI >15
    Intervention: Drug: Abatacept + csDMARD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tania Moin 212 263 9440 Tania.Moin@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700021
Other Study ID Numbers  ICMJE 18-01164
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregg Silverman NYU Langone Health
PRS Account NYU Langone Health
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP