Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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).

Intervention(s) in this Clinical Trial

• Drug: Methotrexate
• Drug: Intraarticular betamethasone
• Drug: Cyclosporine/placebo-cyclosporine

Primary Measures

• ACR20 response

Secondary Measures

• ACR remission (modified)
• Cumulated dose of glucocorticoids
• Development of erosions
• Development of osteopenia

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hvidovre University Hospital

Overall Clinical Trial Officials and Contacts

Merete L Hetland, MD, PhD Principal Investigator Hvidovre Univervsity Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00209859

Study ID Number: 232-002

ClinicalTrials.gov Identifier: NCT00209859

Health Authority: Denmark: Danish Medicines Agency