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Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209859
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209859


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00209859     History of Changes
Other Study ID Numbers: 232-002
First Submitted: September 16, 2005
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Cyclosporine
Cyclosporins
Betamethasone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors