Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment (PSARA)
This study has been completed.
Information provided by (Responsible Party):
First received: May 13, 2009
Last updated: November 20, 2013
Last verified: November 2013
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).
Inflammatory Disease Activity
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- CRP (C-reactive protein) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
- DAS28 (Disease activity score) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
- COMP (cartilage oligomeric matrix protein 1) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
- IL-6 (interleukin 6) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
- s-RAGE (Receptor of Advanced Glycation End products) [ Time Frame: Baseline (before starting treatment), 6 weeks, 6 months after starting treatment ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 80 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with RA and spondyloarthritis starting with either combination therapy of TNFalpha-inhibitor and methotrexate or methotrexate or TNFalpha-inhibitor alone, at Lillehammer Hospital for Rheumatic diseases.Decision about treatment modality will be based on conventional clinial judgement.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00902005
|Lillehammer Hospital for Rheumatic Diseases
|Lillehammer, Oppland, Norway, 2609 |
||Knut Mikkelsen, MD
||Lillehammer Hospital for Rheumatic Diseases
||Gunnbjørg Hjeltnes, MD
||Lillehammer Hospital for Rheumatic Diseases
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Ronda N, Greco D, Adorni MP, Zimetti F, Favari E, Hjeltnes G, Mikkelsen K, Borghi MO, Favalli EG, Gatti R, Hollan I, Meroni PL, Bernini F. Newly identified antiatherosclerotic activity of methotrexate and adalimumab: complementary effects on lipoprotein function and macrophage cholesterol metabolism. Arthritis Rheumatol. 2015 May;67(5):1155-64. doi: 10.1002/art.39039.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 13, 2009
||November 20, 2013
||Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Keywords provided by Revmatismesykehuset AS:
Bone and cartilage markers
Inflammatory disease activity
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Connective Tissue Diseases
Immune System Diseases
Bone Diseases, Infectious
Skin Diseases, Papulosquamous
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action