Treatment of IgG4-Related Disease With Revlimid and Rituximab

Phase 1

Completed

• Conditions: IgG4-related Disease; Autoimmune Pancreatitis; Immunoglobulin G Subclass 4 Related Disease; IgG4-related Sclerosing Cholangitis; Retroperitoneal Fibrosis
• Interventions: Drug: Rituximab; Drug: Lenalidomide

• Registration Number: NCT02705638
• Lead Sponsor: Mayo Clinic

Brief Summary

Among persons with Immunoglobulin G subclass 4 Related Disease (IgG4)-related disease who have persistent or recurrent disease despite standard therapies, does combination therapy with rituximab and revlimid cause a sustained disease remission?

Detailed Description

Immunoglobulin G subclass 4 Related Disease (IgG4-RD) is a recently recognized systemic fibroinflammatory condition. Various manifestations of IgG4-RD were previously recognized in individual organ systems, but these entities (including autoimmune pancreatitis, orbital pseudotumor, Reidel's thyroiditis, retroperitoneal fibrosis, idiopathic sialadenitis and dacryoadenitis, etc) are now recognized as manifestations of a common disease process that can affect any organ system. IgG4-RD is characterized by distinctive histologic findings of tissue infiltration by IgG4-positive plasma cells together with storiform fibrosis and obliterative phlebitis. Both clinical and pathologic consensus diagnostic criteria have been defined. Serum IgG4 concentration is a biomarker for IgG4-RD and is elevated in 70% to 90% of patients with active disease.

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-10
• Study Start: 2016-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab and Lenalidomide	Rituximab	All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15, as well as Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.
Rituximab and Lenalidomide	Lenalidomide	All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15, as well as Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.

Primary Outcome Measures

Name	Time	Method
Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months	24 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States