Rituximab in IgG4-RD: A Phase 1-2 Trial
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT01584388
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Autoimmune Pancreatitis
- Pseudotumor
- Retroperitoneal Fibrosis
- Sialadenitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGRituximab 1000 mg IV times two doses, separated by approximately 15 days.
Study Details
The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.
Key Dates
- Start date
- Apr 30, 2012
- Status verified
- May 2017
- Primary completion
- Jan 31, 2014
- Completion
- Jan 31, 2015
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab
Primary Outcome Measure
IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment [ Time Frame: 6 months ]