Methotrexate and Cyclosporine in Treatment of Early 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