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Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00209859
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:
Hvidovre University Hospital

Brief 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.

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

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.
Study Start Date : October 1998
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ACR20 response

Secondary Outcome Measures :
  1. ACR remission (modified)
  2. Cumulated dose of glucocorticoids
  3. Development of erosions
  4. Development of osteopenia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

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Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Merete L Hetland, MD, PhD Hvidovre Univervsity Hospital
Principal Investigator: Kim Hørslev-Petersen, MD, DSc Rheumatism Hospital Graasten
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00209859    
Other Study ID Numbers: 232-002
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
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