Methotrexate and Cyclosporine in Treatment of 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial 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).
Intervention(s) in this Clinical Trial
- Drug: Methotrexate
- Drug: Intraarticular betamethasone
- Drug: Cyclosporine/placebo-cyclosporine
Outcome Measures for this Clinical Trial
Primary Measures
- ACR20 response
Secondary Measures
- ACR remission (modified)
- Cumulated dose of glucocorticoids
- Development of erosions
- Development of osteopenia
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Hvidovre University Hospital Other
Overall Clinical Trial Officials and Contacts
Merete L Hetland, MD, PhD Principal Investigator Hvidovre Univervsity Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00209859
