Study of Methotrexate in Lupus Erythematosus (SMILE)
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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 placebo-controlled trial of low dose intermittent methotrexate with folic acid is to establish whether methotrexate shows efficacy and safety in controlling disease activity in SLE and preventing flares in disease activity or development of end-organ damage. A second aim will be to document the steroid sparing effect of methotrexate in SLE. A Third aim will be to measure toxicity and utility of methotrexate with folic acid and to perform effectiveness and utility analyses.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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