NCT01584388

Rituximab in IgG4-RD: A Phase 1-2 Trial

Rituximab (RTX) for IgG4-related Disease (IgG4-RD): a Prospective,Open-label Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Retroperitoneal Fibrosis
• Autoimmune Pancreatitis
• Sialadenitis
• Pseudotumor

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 1000 mg IV times two doses, separated by approximately 15 days.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-01-01
• Completion: 2015-01-01
• First posted: 2012-04-25
• Last updated: 2017-07-02
• Results posted: 2017-07-02

Regulatory

• FDA-regulated drug study