Alemtuzumab to Treat Sporadic Inclusion Body Myositis
Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
Participant gender:
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 common inflammatory muscle disease in people over the age of 50, s-IBM
progresses steadily, leading to severe weakness and wasting of the muscles in the arms and
legs. The cause of s-IBM is not known, but it may be an autoimmune disease, in which the
body's immune cells (white blood cells) attack and destroy parts of muscle. Alemtuzumab is a
laboratory-made antibody currently approved to treat certain leukemias. It has also been used
to treat patients with autoimmune conditions such as rheumatoid arthritis, vasculitis,
multiple sclerosis, and tissue rejection associated with transplantation. Alemtuzumab
destroys white blood cells that have a protein called CD52 on their surface and that might be
among the cells attacking muscle.
Patients with s-IBM are eligible for this study. Candidates are screened with physical and
neurological examinations, blood tests, and an electrocardiogram. Participants undergo the
following tests and procedures:
- Campath administration: Patients are admitted to the NIH Clinical Center for 1 to 1-1/2
weeks for intravenous infusions of Campath, given every other day for a total of 4
infusions.
- Follow-up visits after infusions: Patients are monitored for up to 1 year with periodic
blood tests, physical and neurological examinations, medical history, muscle strength
measurements, and a review of symptoms, including the ability to perform daily living
activities.
- Lymphapheresis: Patients undergo this procedure for collecting large numbers of white
blood cells twice - once at the beginning of the study and again after 6 months. Blood
is removed through a needle in an arm vein and flows through a machine that separates it
into its components by centrifugation (spinning). The white cells and plasma are removed
and the red cells and platelets are returned to the patients through the same needle or
through another needle in the other arm.
- Muscle biopsy: Muscle biopsies are done in the operating room under local anesthetic. A
small incision is made in the thigh or upper arm and a small piece of muscle is removed.
Biopsies are done at the beginning of the study and again after 6 months.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)