Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis

PHASE3TerminatedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

November 30, 2012

Study Completion Date

January 31, 2015

Conditions
Wegeners Granulomatosis
Interventions
DRUG

Gusperimus + glucocorticoids

Both severity subgroups will be treated with gusperimus + glucocorticoids up to 12 months.

DRUG

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)."

Trial Locations (1)

128 08

Všeobecná fakultní nemocnice v Praze, Prague

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nordic Pharma SAS

INDUSTRY

NCT01446211 - Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis | Biotech Hunter | Biotech Hunter