Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

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-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.

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 synovitis).

Inclusion Criteria:

• 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 Criteria:

• 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