Status:
COMPLETED
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment
Lead Sponsor:
Revmatismesykehuset AS
Collaborating Sponsors:
Abbott
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18-80 years
Brief Summary
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 methotrexat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00902005
Start Date
April 1 2008
End Date
August 1 2012
Last Update
November 21 2013
Active Locations (1)
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1
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, Norway, 2609