Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
18 Years
N/A
Both
Rheumatoid Arthritis
Trial Information
Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.
Only patients who - regardless of this study - are scheduled and permitted to receive
anti-TNF-alpha treatment because of their RA will be asked to participate. No patient will
be recruited only for the sake of the study. The prescribing physicians will not be
influenced by the study as to what form of anti-TNF-alpha therapy they should select.
Inclusion Criteria:
- Must have active RA (DAS28 >5.1)
- Must have x-ray evidence of an erosive disease,
- Must be eligible for but have never received any anti-TNF treatment,
- Must fulfill the 1987 criteria of the American College of Rheumatology classification
criteria for a diagnosis of RA, for at least 3 months,
- Must have failed standard therapy (methotrexate or leflunomide).
Exclusion Criteria:
- Must not be a women who is pregnant or breastfeeding,
- Must not have a history of any malignancy,
- Must not have an active infection,
- Must not be prone to infection,
- Must not have tuberculosis, hepatitis B, hepatitis C, or HIV,
- Must not have septic arthritis of a native prosthetic joint within the last 12
months,
- Must not have NYHA grade 3 or 4 heart failure,
- Must not have a history of demyelinating disease or systemic lupus erythematosis.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells
Outcome Time Frame:
Weeks 0, 4, and 14.
Safety Issue:
No
Authority:
Hungary: Not Applicable
Study ID:
P05521
NCT ID:
NCT00724672
Start Date:
September 2008
Completion Date:
July 2009
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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