Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00209859
• Lead Sponsor: Hvidovre University Hospital

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 1998-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Last Update Submitted: 2005-09-16
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21
• Study Completion: 2007-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ACR20 response

Secondary Outcome Measures

Name	Time	Method
ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark