Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00837434
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Etanercept — DRUG
    50 mg dose of etanercept by subcutaneous injection
  • Adalimumab — DRUG
    40 mg dose of adalimumab by subcutaneous injection

Study Details

Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA. Additionally, there are 4 optional sub-studies as part of the trial: * B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly reductions in B-cell memory occur * Vaccine Response Sub-Study to assess B cell memory in response to immunization with hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether T-cell vaccine responses are altered with TNF blockade * Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the tonsil dendritic cells and germinal cells * Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells in lymphoid tissue.

Key Dates

Start date
Mar 31, 2009
Status verified
Aug 2021
Primary completion
Nov 30, 2013
Completion
Jan 31, 2014

Study Design

Enrollment
63 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Etanercept
    Participants receive a subcutaneous injection of etanercept once every week for 24 weeks
  • Experimental: Adalimumab
    Participants receive a subcutaneous injection of adalimumab once every 2 weeks for 24 weeks

Primary Outcome Measure

Percentage of CD27+ Switched Memory B Cells at Week 12 [ Time Frame: Week 12 ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
University of California, San FranciscoSan FranciscoCalifornia94143-
Yale University School MedicineNew HavenConnecticut06519-
University of ChicagoChicagoIllinois60637-
Feinstein Institute for Medical ResearchManhassetNew York11030-
University of RochesterRochesterNew York14642-
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Alabama· Birmingham, ALUniversity of California, San Francisco· San Francisco, CAYale University School Medicine· New Haven, CTUniversity of Chicago· Chicago, ILFeinstein Institute for Medical Research· Manhasset, NYUniversity of Rochester· Rochester, NY

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