Effects of a T Cell-Depleting Monoclonal Antibody, Alemtuzumab, in Patients With Inclusion Body Myositis: A Pilot Clinicopathological Study

Date de début de l'étude : 1 mars 2004

* Only patients who are currently enrolled in protocol 02-N-0121 Study of Immune Dysregulation in Patients with Sporadic Inclusion Body Myositis (s-IBM) will be considered for enrollment in protocol 04-N-0133. INCLUSION CRITERIA: Patients with confirmed diagnosis of s-IBM willing to undergo therapy with Alemtuzumab. Willingness and legal ability to give and sign informed study consent. Willingness to travel to the Clinical Center for planned studies and treatment as required by protocol. Men and women of reproductive potential must agree to use an acceptable method of birth control during and for six months after completion of treatment. Availability of tissue for testing. This will include muscle and peripheral blood lymphocytes isolated through routine lymphocytapheresis or phlebotomy. EXCLUSION CRITERIA: Immunosuppressive drug therapy at the time of or 6 months prior to enrollment. Specifically, candidates may not be taking Prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide methotrexate, or other agents whose concomitant use may enhance the toxicity of Alemtuzumab. Any medical or personal difficulties that precludes serial follow-up visits. Any active malignancy. Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol. Platelet count less than 100,000/mm(3). Hemoglobin less than 9.0 mg/dl. Any known immunodeficiency syndrome included HIV infection. Any history of cardiac insufficiency, major vascular disease, or unstable coronary artery disease. Any history of systemic or pulmonary edema. Any history of previous treatment with monoclonal antibodies or sensitivity to the study drug (Alemtuzumab), pre-medication regimen, or prophylactic agents. History of chronic hypotension (SBP less than 100 mmHg). Any medical condition that would likely increase the risk of side effects of the study drug or confound the interpretation of the data including active infections. Pregnancy and active nursing (breast feeding). History of uncontrolled thyroid disease or a history of autoimmune thyroiditis.