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
II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in
III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of
treatment in these arms.
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
Patients are followed for one year.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
PROTOCOL ENTRY CRITERIA:
Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy
Heart failure and/or arrhythmia of less than 3 months duration
Hepatic: AST/ALT no greater than 3 times upper limit of normal
Renal: Creatinine no greater than 2.5 mg/dL
Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use
effective contraception; No clinical evidence of sepsis or active infection (e.g.
meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to
cyclosporine or muromonab-CD3; No other severe concurrent diseases