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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: etanercept
* Drug: infliximab
* Drug: adalimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ETA<br>RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly | Drug: etanercept<br>* etanercept 50 mg subcutaneously once weekly<br>* Other names: Enbrel®;|
| IFX<br>RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6 | Drug: infliximab<br>* infliximab 3 mg/kg IV at Weeks 0, 2, and 6<br>* Other names: Remicade®, SCH 215596;|
| ADA<br>RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly | Drug: adalimumab<br>* adalimumab 40 mg subcutaneously biweekly<br>* Other names: Humira®;|
| non-diseased controls<br>Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression (under- or overexpression) in the peripheral blood mononuclear cells |  | Weeks 0, 4, and 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity measured by DAS28 |  | Weeks 0 and 14 |