Rituximab in IgG4-related Disease: A Phase 1-2 Trial
The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Rituximab in IgG4-Related Disease: A Phase 1-2 Trial|
- Primary (Disease Response) [ Time Frame: Six months ] [ Designated as safety issue: No ]
Disease Response at six months is the primary endpoint in this trial. The ability to maintain disease remission off glucocorticoids is an important clinical measure in this disease.
Disease Response - Disease Response is defined at 6 months as:
- Improvement of > 2 points in the IgG4-RD RI over baseline
- No glucocorticoid or other immunosuppressive drug use between months 4 and 6
- No disease flares, as assessed by the IgG4-RD Responder Index.
|Study Start Date:||April 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
Other Name: Rituxan
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584388
|Study Chair:||John H Stone, MD, MPH||Massachusetts General Hospital (Rheumatology Unit)|
|Study Director:||Arezou Khosroshahi, MD||Massachusetts General Hospital (Rheumatology Unit)|