Status:
COMPLETED
Alemtuzumab to Treat Sporadic Inclusion Body Myositis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Myositis, Inclusion Body
Eligibility:
All Genders
25-80 years
Phase:
PHASE2
Brief Summary
This study will examine the safety and effectiveness of alemtuzumab (Campath® (Registered Trademark)) for improving muscle strength in patients with sporadic inclusion body myositis (s-IBM). The most ...
Detailed Description
Sporadic Inclusion-Body Myositis (s-IBM) is the most common muscle disease in patients above the age of 50 years. It is an inflammatory myopathy mediated by sensitized, cytotoxic CD8+ T cells that clo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00079768
Start Date
March 1 2004
End Date
March 1 2007
Last Update
June 17 2010
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892