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.
Phase:
Phase 3
Details
Lead Sponsor:
University Health Network, Toronto
Collaborators:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre