At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Rituximab +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis
In Brief
A Phase 3 clinical trial evaluating Rituximab, Placebo, and 5 other interventions for Lupus Nephritis. Completed, enrolled 144 participants.
Detailed Summary
This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF) compared with placebo in combination with MMF in subjects diagnosed with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedJan 2006
Primary CompletionJan 2009
Study CompletionJan 2013
TodayJul 2026
First PostedJan 26, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2009
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.4 years ago
Interventions
Rituximabdrug
Rituximab was provided as a sterile solution for injection.
Placebodrug
Placebo was provided as a sterile solution for injection.
Mycophenolate mofetildrug
Methylprednisolonedrug
Diphenhydraminedrug
Acetaminophendrug
Prednisonedrug