Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 30, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

rituximab

"1. Rituximab of 1000 mg given 2 weeks apart. On day the of rituximab, and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5.~2. A treatment dose rituximab of 1000mg given 2 weeks apart and 'pulse' methylprednisolone 250mg IV be given followed by prednisolone 30mg/day from Day 2 to Day 5, and 'pulse' cyclophosphamide 500mg/m2 at baseline and day 14.~3. Sequential therapy with oral cyclophosphamide (50 to 100 mg/day) for 6 months followed by azathioprine (up to 2.5mg/kg/day) for maintenance up to 12 months. Oral prednisolone will be given at 0.5 mg/kg/day (up to 30 mg daily) for 4 weeks, tapered by 5 mg every 2 weeks thereafter until 5mg /day for the rest of the study period."

Trial Locations (1)

Unknown

Department of Medicine and Therapeutics, Hong Kong

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER

NCT00556192 - Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter