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|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 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.
|Contact: John H Stone, MD, MPHfirstname.lastname@example.org|
|Contact: Mollie N Carruthers, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: John H Stone, MD, MPH 617-726-7938 firstname.lastname@example.org|
|Contact: Judith G Oakley, BA, CCRC 617-724-2567 email@example.com|
|Principal Investigator: John H Stone, MD, MPH|
|Sub-Investigator: Zachary Wallace, MD|
|Sub-Investigator: Mollie Carruthers, MD|
|Sub-Investigator: Vikram Deshpande, MD|
|Sub-Investigator: Arezou Khosroshahi, MD|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55901|
|Contact: Mark Topazian, MD 507-284-7602 Topazian.Mark@mayo.edu|
|Contact: Lori A Bergstrom, RN 507-538-1887 Bergstrom.Lori@mayo.edu|
|Principal Investigator: Mark Topazian, MD|
|Sub-Investigator: Suresh Chari, MD|
|Sub-Investigator: Thomas Smyrk, MD|
|Study Chair:||John H Stone, MD, MPH||Massachusetts General Hospital (Rheumatology Unit)|
|Study Director:||Arezou Khosroshahi, MD||Massachusetts General Hospital (Rheumatology Unit)|