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| Name | Class |
|---|---|
| Departmet of Rheumatology, J Dietl Hospital, Krakow, Poland | UNKNOWN |
The aim of this study is to evaluate the influence of anti tumor necrosis factor-alpha (TNF-α) treatment on blood pressure, endothelial function and immune cell phenotype in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological treatment | Experimental | Patients with high disease activity receiving biological treatment according to rheumatologic indication:
|
|
| control group | Placebo Comparator | Patients with high disease activity receiving other than biological treatment and receiving placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | biological treatment according to rheumatologic indication |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in blood pressure | Ambulatory Blood Pressure Monitoring (ABPM) | prior to receiving anti-TNF-α treatment, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in endothelial function | Flow Mediated Dilatation / Endo Pat | prior to receiving anti-TNF-α treatment, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in immune cell subset populations from baseline | determination of subsets, activation markers, intracellular cytokine production | prior to receiving anti-TNF-α treatment, 12 weeks |
Inclusion Criteria:
For patients suffering from rheumatoid arthritis:
For patients suffering from Ankylosing Spondylitis:
For patients suffering from Psoriatic Arthritis:
- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)
If peripheral joints are affected:
active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months
Criteria of active disease (all have to be met):
If axial joints are affected:
Criteria of active disease (all must be present):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Guzik, MD, PhD | Jagiellonian University | Study Chair |
| Bogdan Batko, MD, PhD | Department of Rheumatology, J. Dietl Hospital, Krakow, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katedra Chorób Wewnętrznych i Medycyny Wsi, Uniwersytet Jagielloński | Recruiting | Krakow, Skarbowa 4 | 31-121 | Poland |
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| Adalimumab |
| Drug |
biological treatment according to rheumatologic indication |
|
| Certolizumab | Drug | biological treatment according to rheumatologic indication |
|
| Infliximab | Drug | biological treatment according to rheumatologic indication |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000068879 | Adalimumab |
| D000068582 | Certolizumab Pegol |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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