Autoimmune Pancreatitis Clinical Trial
Rituximab in IgG4-Related Disease: A Phase 1-2 Trial
|Source||Massachusetts General Hospital|
|Phase||Phase 1/Phase 2|
|Start date||April 2012|
|Completion date||January 2015|
The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.
This two-center trial will enroll at total of 30 patients with IgG4-RD. The two participating sites are the Massachusetts General Hospital (Boston, MA) and the Mayo Clinic (Rochester, MN). All patients will receive rituximab 1 gram intravenously times two doses, separated by approximately 15 days. The primary efficacy outcome - disease remission and successful completion of the glucocorticoid taper - will be assessed at six months. Patients will be followed on the protocol for an additional six months after measurement of the primary outcome.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment