Trials / Completed
CompletedNCT02705638
Treatment of IgG4-Related Disease With Revlimid and Rituximab
Treatment of IgG4-Related Disease With Revlimid and Rituximab: The TIGR2 Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Immunoglobulin G Subclass 4 Related Disease
- IgG4-related Disease
- Autoimmune Pancreatitis
- IgG4-related Sclerosing Cholangitis
- Retroperitoneal Fibrosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15. |
| DRUG | Lenalidomide | All subjects will receive Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2019-04-01
- Completion
- 2019-04-01
- First posted
- 2016-03-10
- Last updated
- 2019-07-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02705638. Inclusion in this directory is not an endorsement.