Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209859
• Other study ID #: 232-002
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2005
• Last updated: September 16, 2005
• Start date: October 1998
• Est. completion date: November 2007

Study information

• Verified date: September 2005
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate

• Intraarticular betamethasone

• Cyclosporine/placebo-cyclosporine

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response
Secondary	ACR remission (modified)
Secondary	Cumulated dose of glucocorticoids
Secondary	Development of erosions
Secondary	Development of osteopenia