A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)
|ClinicalTrials.gov Identifier: NCT00724672|
Recruitment Status : Withdrawn
First Posted : July 29, 2008
Last Update Posted : June 1, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: etanercept Drug: infliximab Drug: adalimumab|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official 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.|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||July 2009|
|Estimated Study Completion Date :||July 2009|
RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly
etanercept 50 mg subcutaneously once weekly
Other Name: Enbrel®
RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6
infliximab 3 mg/kg IV at Weeks 0, 2, and 6
Other Name: Remicade®, SCH 215596
RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly
adalimumab 40 mg subcutaneously biweekly
Other Name: Humira®
Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained.
Primary Outcome Measures :
- Gene expression (under- or overexpression) in the peripheral blood mononuclear cells [ Time Frame: Weeks 0, 4, and 14. ]
Secondary Outcome Measures :
- Disease Activity measured by DAS28 [ Time Frame: Weeks 0 and 14 ]
Biospecimen Retention: Samples With DNA
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