Rituximab in IgG4-related Disease: A Phase 1-2 Trial

Status Completed

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01584388
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2012
Completion date	January 2015

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