Trial | NCT00209859  Report issue

Title

Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    160
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).
Study Started
Oct 31
1998
Study Completion
Nov 30
2007
Last Update
Sep 21
2005
Estimate

Drug Methotrexate

Drug Intraarticular betamethasone

Drug Cyclosporine/placebo-cyclosporine

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
No Results Posted