Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00209859
First received: September 16, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hvidovre University Hospital

Additional 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
Study First Received: September 16, 2005
Last Updated: September 16, 2005
Health Authority: Denmark: Danish Medicines Agency

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

ClinicalTrials.gov processed this record on November 27, 2014