Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment (PSARA)
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|ClinicalTrials.gov Identifier: NCT00902005|
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : November 21, 2013
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|Condition or disease|
|Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Endothelial Dysfunction Inflammatory Disease Activity|
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||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|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2012|
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
- 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 [ Time Frame: Baseline (before treatment starts), 6 weeks and 6 months after starting treatment ]
- CRP (C-reactive protein) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
- DAS28 (Disease activity score) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
- COMP (cartilage oligomeric matrix protein 1) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
- IL-6 (interleukin 6) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
- s-RAGE (Receptor of Advanced Glycation End products) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ]
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902005
|Lillehammer Hospital for Rheumatic Diseases|
|Lillehammer, Oppland, Norway, 2609|
|Study Chair:||Knut Mikkelsen, MD||Lillehammer Hospital for Rheumatic Diseases|
|Principal Investigator:||Gunnbjørg Hjeltnes, MD||Lillehammer Hospital for Rheumatic Diseases|
|Responsible Party:||Revmatismesykehuset AS|
|Other Study ID Numbers:||
|First Posted:||May 14, 2009 Key Record Dates|
|Last Update Posted:||November 21, 2013|
|Last Verified:||November 2013|
Bone and cartilage markers
Inflammatory disease activity
Connective Tissue Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Bone Diseases, Infectious