Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

Phase 2

Completed

• Conditions: Myocarditis; Giant Cell Myocarditis

• Registration Number: NCT00004482
• Lead Sponsor: Mayo Clinic

Brief Summary

OBJECTIVES:

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.

Detailed Description

PROTOCOL OUTLINE:

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.

Study Timeline

• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Study Start: 1999-12
• Primary Completion: 2005-07
• Study Completion: 2006-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States