Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis
Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Methotrexate (Drug); Intraarticular betamethasone (Drug); Cyclosporine/placebo-cyclosporine (Drug)
Phase: Phase 4
Sponsored by: Hvidovre University Hospital
Official(s) and/or principal investigator(s):
Merete L Hetland, MD, PhD, Principal Investigator, Affiliation: Hvidovre Univervsity Hospital
Kim Hørslev-Petersen, MD, DSc, Principal Investigator, Affiliation: Rheumatism Hospital Graasten
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
Official title: Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: ACR20 response
ACR remission (modified)
Cumulated dose of glucocorticoids
Development of erosions
Development of osteopenia
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).
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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.
- 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
- Poorly regulated diabetes
- Anticoagulant treatment
- Known allergy to the medicine
- Medicamental interactions
- Other inflammatory rheumatic diseases
Locations and Contacts
Hvidovre University Hospital, Hvidovre 2650, Denmark
Starting date: October 1998
Ending date: November 2007
Last updated: September 16, 2005