Status:
COMPLETED
Study of Methotrexate in Lupus Erythematosus
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The treatment of systemic lupus erythematosus (SLE) has been aimed at decreasing mortality and morbidity because the etiology of the disease is unknown. The general aim of this multicentre randomized ...
Detailed Description
SLE is a chronic systemic autoimmune and inflammatory disease. Approximately 65% of patients develop SLE between 16 and 55 years of age, and it is 8-10 times more common in women. Overall prevalence i...
Eligibility Criteria
Inclusion
- men and women with diagnosis of SLE
- 18 years and above
- negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study
- Subject with active disease as defined by SLAM of at least 8
- SLICC/ACR damage index of less or equal to 15
- Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study
- subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments
- must understand either French or English and can give written informed consent
Exclusion
- previous history of hypersensitivity or intolerance to methotrexate or folic acid
- total SLAM of less than 8 or total SLICC/ACR score of more than 15.
- history of medical non-compliance or inability to comply with instructions
- subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry.
- clinically significant acute or chronic liver disease with the exception of autoimmune liver disease
- alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week
- insulin requiring diabetes mellitus with morbid obesity
- renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl
- interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO \< 70% of predicted) without evidence of pulmonary hypertension.
- WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm.
- prior use of methotrexate to treat SLE
- use of sulfa drugs that may potentiate the folate antagonistic effects of MTX
- non-steroidal anti-inflammatory drugs will be allowed throughout the trial unless there is evidence of renal failure or other contra-indications to these drugs. Their con-comitant use with MTX is routine in patients with rheumatoid arthritis.
- use of another cytotoxic or immunosuppressive drug such as cyclophosphamide, azathioprine, chlorambucil, cyclosporin or trimetoprime currently or in the preceding 6 months.
- current participation in any other drug trial or participation in such a trial in the previous one month.
- serologic evidence of infection with HIV
- biologic potential for pregnancy and not utilizing effective means of contraception
- recently (less than 6 months) diagnosed malignancy
- vitamin B12 deficiency
Key Trial Info
Start Date :
June 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00470522
Start Date
June 1 1995
End Date
December 1 2001
Last Update
May 7 2007
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8