Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment

Study Overview
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Brief Summary
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The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).

Official Title
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Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in RA and Spondyloarthritis Patients, Treated With TNFalpha-inhibitors in Combination With Methotrexate or Methotrexate or TNFalpha-inhibitors Alone - a Prospective Study

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Endothelial Dysfunction, Inflammatory Disease Activity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18-80 years Able and willing to give written informed consent, and to comply with the requirements of the study protocol. Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by Moll and Wright for the diagnosis psoriatic arthritis, or the modified New York diagnostic criteria for ankylosing spondylitis. Clinical indication for starting treatment with methotrexate, TNFalpha- inhibitor or combination therapy. Use of reliable method of contraception for women with childbearing potential. Exclusion Criteria: Lack of cooperativity Positive serology for hepatitis B or C History of positive HIV status. History of tuberculosis or untreated tuberculosis. PPD more than 15 mm in previously BCG immunized subjects. PPD 6 mm or more if not previously BCG immunized. Histoplasmosis or Listeriosis Persistent or recurrent infections Any inflammatory disease of permanence not related to RA, PSA or AS. Pregnancy or breast-feeding. Use of prednisolone more than 10 mg daily for 2 weeks at inclusion. Use of TNFalpha-inhibitor the last 4 weeks. History of cancer. Uncontrolled diabetes. Congestive heart failure (Nyha 3-4) Recent stroke (within 3 months) Previous diagnosis or signs of central nervous system demyelinating disease. Previously diagnosed immunodeficiency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Rheumatic patients<br>Three groups: RA patients: 30 starting on Methotrexate, 30 starting on combination of Methotrexate and TNFalpha inhibitor. PSA patients: 20 starting on Methotrexate, 20 starting on combination of Methotrexate and TNFalpha inhibitor. AS patients: 20 starting on TNFalpha inhibitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone |  | Baseline (before treatment starts), 6 weeks and 6 months after starting treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP (C-reactive protein) |  | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | 
| DAS28 (Disease activity score) |  | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | 
| COMP (cartilage oligomeric matrix protein 1) |  | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | 
| IL-6 (interleukin 6) |  | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | 
| s-RAGE (Receptor of Advanced Glycation End products) |  | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial dysfunction, Bone and cartilage markers, Inflammatory disease activity, Rheumatoid arthritis, Psoriatic arthritis, Ankylosing Spondylitis