4
Participants
Start Date
November 30, 2011
Primary Completion Date
November 30, 2012
Study Completion Date
January 31, 2015
Gusperimus + glucocorticoids
Both severity subgroups will be treated with gusperimus + glucocorticoids up to 12 months.
cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids
"Severe subgroup: will receive intravenous cyclophosphamide pulses for at least 13 weeks and 22 weeks at maximum, followed by methotrexate + glucocorticoids after achieving a response with BVAS ≤ 2. Patients intolerant to methotrexate and patients with impaired renal function will receive azathioprine + glucocorticoids .~Non-severe subgroup: will receive methotrexate + glucocorticoids (or azathioprine + glucocorticoids for those previously intolerant to methotrexate or with impaired renal function)."
Všeobecná fakultní nemocnice v Praze, Prague
Lead Sponsor
Nordic Pharma SAS
INDUSTRY