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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 June 2015
Main ID:  NCT00724672
Date of registration: 25/07/2008
Prospective Registration: Yes
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
Scientific title: 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.
Date of first enrolment: September 2008
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT00724672
Study type:  Observational
Study design:  Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: adalimumab
Drug: etanercept
Drug: infliximab
Primary Outcome(s)
Gene expression (under- or overexpression) in the peripheral blood mononuclear cells [Time Frame: Weeks 0, 4, and 14.]
Secondary Outcome(s)
Disease Activity measured by DAS28 [Time Frame: Weeks 0 and 14]
Secondary ID(s)
P05521
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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