Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
NCT ID: NCT00902005
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
145 participants
OBSERVATIONAL
2008-04-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rheumatic patients
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Revmatismesykehuset AS
OTHER
Responsible Party
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Principal Investigators
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Knut Mikkelsen, MD
Role: STUDY_CHAIR
Lillehammer Hospital for Rheumatic Diseases
Gunnbjørg Hjeltnes, MD
Role: PRINCIPAL_INVESTIGATOR
Lillehammer Hospital for Rheumatic Diseases
Locations
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Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, Norway
Countries
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References
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Hokstad I, Deyab G, Wang Fagerland M, Lyberg T, Hjeltnes G, Forre O, Agewall S, Mollnes TE, Hollan I. Tumor necrosis factor inhibitors are associated with reduced complement activation in spondylarthropathies: An observational study. PLoS One. 2019 Jul 23;14(7):e0220079. doi: 10.1371/journal.pone.0220079. eCollection 2019.
Deyab G, Hokstad I, Whist JE, Smastuen MC, Agewall S, Lyberg T, Ronda N, Mikkelsen K, Hjeltnes G, Hollan I. Methotrexate and anti-tumor necrosis factor treatment improves endothelial function in patients with inflammatory arthritis. Arthritis Res Ther. 2017 Oct 17;19(1):232. doi: 10.1186/s13075-017-1439-1.
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.
Hjeltnes G, Hollan I, Forre O, Wiik A, Lyberg T, Mikkelsen K, Agewall S. Relations of serum COMP to cardiovascular risk factors and endothelial function in patients with rheumatoid arthritis treated with methotrexate and TNF-alpha inhibitors. J Rheumatol. 2012 Jul;39(7):1341-7. doi: 10.3899/jrheum.111401. Epub 2012 Jun 1.
Other Identifiers
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S-07377b
Identifier Type: -
Identifier Source: org_study_id