Drug: methotrexate 0.3 mg/kg/week, to a maximum and optimal dose of 25 mg/week
Hospices Civils de Lyon
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).
Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).
(and 5 more...)
18 Years to 80 Years (Adult, Senior)
July 7, 2006
October 10, 2007
Christian PAGNOUX Paris, France
† Study has passed its completion date and status has not been verified in more than two years.