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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETA | RA patients who were scheduled to receive etanercept 50 mg subcutaneously once weekly |
| |
| IFX | RA patients who were scheduled to receive infliximab 3 mg/kg IV at Weeks 0, 2, and 6 |
| |
| ADA | RA patients who were scheduled to receive adalimumab 40 mg subcutaneously biweekly |
| |
| non-diseased controls | Healthy individuals who contributed their RNA/cDNA samples prior to the study and for whom ethical approval has already been obtained. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | etanercept 50 mg subcutaneously once weekly |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression (under- or overexpression) in the peripheral blood mononuclear cells | Weeks 0, 4, and 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity measured by DAS28 | Weeks 0 and 14 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from a single center at the National Institute of Rheumatology and Physiotherapy, Budapest, the largest center for biological therapy in Hungary. Subjects will be patients who are scheduled and permitted to receive anti-TNF-alpha treatment due to their rheumatoid arthritis.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000069285 | Infliximab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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Blood samples
| infliximab | Drug | infliximab 3 mg/kg IV at Weeks 0, 2, and 6 |
|
|
| adalimumab | Drug | adalimumab 40 mg subcutaneously biweekly |
|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D061067 | Antibodies, Monoclonal, Humanized |