Status:
WITHDRAWN
A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00724672
Start Date
September 1 2008
End Date
July 1 2009
Last Update
June 1 2015
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