Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Dr. Larry W. Moreland
Study ID
NCT02353780
Phase
PHASE4
Status
Terminated

Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • TNF Antagonist (enbrel, humire, remicade, cimzia, symponi) — DRUG
    TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen.
  • Abatacept — DRUG
    Abatacept; SQ; specifics to be determined by the treating rheumatologist.
  • Tocilizumab — DRUG
    Tocilizumab; SQ; specifics determined by the treating rheumatologist.

Study Details

An Agency for Healthcare Research and Quality executive summary indicated that better comparative effectiveness trial designs are needed to determine the relative merits of existing versus new and expensive biologic drug therapies for rheumatoid arthritis (RA). There are now 9 biologic therapies approved for treating RA. Four classes of biologics (TNF antagonists, B-cell inhibitors, T-cell co-stimulator blocker, and Interleukin-6 receptor blocker) are approved for use in RA patients with moderate or severe disease activity. Several critical questions have arisen, such as 1) what therapy should be prescribed after failure of methotrexate and/or other oral disease modifying antirheumatic drugs (DMARDs) to adequately control disease activity; 2) what is the level of efficacy of the various biologic therapies when compared in head-to-head trials; and 3) what are the mechanisms associated with failure of methotrexate and/or other oral DMARD therapy and responsiveness to biologic therapies. The MAZERATI study will provide the foundation for answering these questions and determining the mechanisms associated with these biologic therapies.

Key Dates

Start date
Mar 31, 2015
Status verified
Sep 2020
Primary completion
Dec 30, 2017
Completion
Nov 30, 2018

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Different TNF inhibitor
    The participant will be prescribed any TNF antagonist in this arm. The treating rheumatologist selects the TNF antagonist and the appropriate options for that therapy.
  • Active Comparator: Abatacept
    The participant will be prescribed abatacept in this arm. The treating rheumatologist selects the appropriate options for that therapy.
  • Active Comparator: Tocilizumab
    The participant will be prescribed tocilizumab. The treating rheumatologist selects the appropriate options for that therapy.

Primary Outcome Measure

Mechanistic Comparisons (Changes in Frequencies of Peripheral Blood Immune Cell Subsets Following Institution of a Subcutaneously Administered TNF Antagonist, Tocilizumab or Abatacept.) [ Time Frame: 0 to 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15261-

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By research site
University of Pittsburgh· Pittsburgh, PA

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