Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Hvidovre University Hospital

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Intraarticular betamethasone

Drug: Cyclosporine/placebo-cyclosporine

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT00209859

232-002

Details and patient eligibility

About

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.

Full 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 synovitis).

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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