Status:
COMPLETED
Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-spari...
Detailed Description
Design: Multicentre, prospective, randomised, double-blind study with parallel design. Selection of patients: Patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent s...
Eligibility Criteria
Inclusion
- Synovitis in at least 2 joints.
- Compliance with the ACR criteria for RA.
- Duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration).
- Informed consent.
Exclusion
- Age less than 18 years or more than 75 years
- Lack of co-operability.
- Previous treatment with DMARD
- Corticosteroid treatment during the preceding 4 weeks.
- Contra indications for the treatments (awaiting the recommendations from Novartis)
- Previous or present malignant or premalignant disease
- Poorly regulated hypertension
- Impaired renal function
- Immuno defective diseases, including HIV
- Cardiac or pulmonary insufficiency
- Serious arteriosclerosis
- Serious granulocytopenia or thrombocytopenia
- Impaired liver function (liver enzymes more than twice the highest normal limit).
- Alcohol consumption of more than 3 drinks a week.
- Poorly controlled epilepsy
- Lack of contraception in fertile patients
- Pregnancy and lactation
- Psoriasis
- Poorly regulated diabetes
- Anticoagulant treatment
- Known allergy to the medicine
- Medicamental interactions
- Other inflammatory rheumatic diseases
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00209859
Start Date
October 1 1998
End Date
November 1 2007
Last Update
September 21 2005
Active Locations (1)
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1
Hvidovre University Hospital
Hvidovre, Denmark, 2650