A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00724672
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • etanercept — DRUG
    etanercept 50 mg subcutaneously once weekly
  • infliximab — DRUG
    infliximab 3 mg/kg IV at Weeks 0, 2, and 6
  • adalimumab — DRUG
    adalimumab 40 mg subcutaneously biweekly

Study Details

This 14-week study will observe the gene expression of certain immune cells in patients with rheumatoid arthritis who receive etanercept, infliximab, and adalimumab. Patients at the National Institute of Rheumatology and Physiotherapy, Budapest, who are already scheduled to receive an anti-TNF agent will be asked to participate in this study. Patients will receive their treatment (etanercept, infliximab, or adalimumab) as scheduled, and have blood samples collected during the study and analyzed by the laboratory. Patient's response to their treatment will also be studied based on x-rays and other examinations.

Key Dates

Start date
Sep 30, 2008
Status verified
May 2015
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
0 participants (actual)

Arms

  • Arm: ETA
    RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
  • Arm: IFX
    RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6
  • Arm: ADA
    RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
  • Arm: non-diseased controls
    Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.

Primary Outcome Measure

Gene expression (under- or overexpression) in the peripheral blood mononuclear cells [ Time Frame: Weeks 0, 4, and 14. ]

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