Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

This study has been completed.
Information provided by:
Hvidovre University Hospital Identifier:
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Methotrexate
Drug: Intraarticular betamethasone
Drug: Cyclosporine/placebo-cyclosporine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • ACR20 response

Secondary Outcome Measures:
  • ACR remission (modified)
  • Cumulated dose of glucocorticoids
  • Development of erosions
  • Development of osteopenia

Estimated Enrollment: 160
Study Start Date: October 1998
Estimated Study Completion Date: November 2007
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).


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00209859

Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Merete L Hetland, MD, PhD Hvidovre Univervsity Hospital
Principal Investigator: Kim Hørslev-Petersen, MD, DSc Rheumatism Hospital Graasten
  More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00209859     History of Changes
Other Study ID Numbers: 232-002
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents processed this record on April 23, 2014