Conditions: Retroperitoneal Fibrosis Autoimmune Pancreatitis Sialadenitis Pseudotumor
Keywords: Type 1 autoimmune pancreatitis IgG4-related sclerosing cholangitis Chronic sclerosing sialadenitis Lacrimal glands Orbital pseudotumor IgG4-related tubulointerstitial nephritis Lymphadenopathy Pachymeningitis Aorta Peri-aortitis Retroperitoneal fibrosis Riedel's thyroiditis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None

Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab 1000 mg IV times two doses, separated by approximately 15 days.

Protocol document: