Clinical Trial: Treatment of IgG4-Related Disease With Revlimid and Rituximab
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Treatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 Trial
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 Summary: 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.
Sponsor: Mayo Clinic
Current Primary Outcome: Number of subjects in remission for Immunoglobulin G subclass 4 Related Disease at 24 months [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: March 7, 2016
Date Started: April 2016
Date Completion: April 2019
Last Updated: September 12, 2016
Last Verified: September 2016