Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Treatments: Betamethasone; Cyclosporine; Cyclosporins; Methotrexate

Criteria

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