Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.
II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.
III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.
|Myocarditis Giant Cell Myocarditis||Drug: Cyclosporine Drug: methylprednisolone Drug: Muromonab-CD3 Drug: prednisone||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Study Start Date:||December 1999|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
This is a randomized, open label, multicenter study.
Patients are randomized to receive standard care with immunosuppression (arm I) or standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).
Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year.
Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).
Patients are followed for one year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004482
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Leslie T. Cooper, Jr.||Mayo Clinic|