Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis
Status:
Completed
Trial end date:
2010-05-20
Target enrollment:
Participant gender:
Summary
This study will examine whether infliximab (Remicade ) is safe and effective for the
treatment of dermatomyositis and polymyositis. Infliximab blocks the effect of a protein
called tumor necrosis factor (TNF), which is associated with harmful inflammation in many
diseases.
Patients 18 years of age and older with active dermatomyositis or polymyositis that does not
respond adequately to treatment with methotrexate and corticosteroids may be eligible for
this study. Candidates will be screened with a medical history, physical examination, blood
and urine tests, chest x-ray, pulmonary function test, skin test for tuberculosis, HIV test,
electromyography (described below), manual muscle testing, and functional assessments.
Magnetic resonance imaging (described below) will be done to assess the degree and location
of inflammation in the involved limbs. An electrocardiogram and echocardiogram will be done
if recent ones are not available. Patients who qualify for the study will be asked to undergo
two muscle biopsies (surgical removal and analysis of small pieces of muscle tissue), one
before initiation of treatment and another on the 16th week .
Participants will be randomly assigned to receive either 3 mg/kg body weight of infliximab or
a placebo (inactive substance) by infusion through a vein over 2 hours. The infusions will be
given at the beginning of the treatment period (week 0) and at weeks 2, 6 and 14. At week 16,
strength will be assessed by manual muscle testing. Patients who improved with treatment will
continue with the same infusion dose on weeks 18, 22, 30, and 38. Those who do not improve
will be assigned by random allocation to receive either 5 mg/kg body weight or 10/mg/kg body
weight of infliximab on weeks 18, 22, 30 and 38. Those who did not improve who were
previously on the placebo infusion will receive an extra dose of either 5 mg/kg or 10 mg/kg
body weight of infliximab on week 16, while those patients who were previously on 3 mg/kg
body weight of infliximab who failed to meet the improvement criteria will receive an
infusion containing no medication on week 16. Patients will be admitted to the hospital for
infusions at weeks 0, 14 and 38; the rest will be given on an outpatient basis. After the
38th week, all infusions will be stopped and patients will be assessed on the 40th week.
Participants will undergo some or all of the following tests and evaluations during
treatment:
- Blood tests every week to look for antibodies seen with muscle inflammation. Some of the
blood samples will be stored for later testing, including genetic studies to find
genetic differences related to inflammation.
- Skin test for tuberculosis
- Chest x-rays at the beginning of the study (if a recent one is not available) and again
at weeks 16 and 40 to look for active infection, detect signs of past exposure or
infection with diseases such as tuberculosis, and assess the presence of lung disease
that might be related to the myositis.
- MRI (usually of the legs) at the beginning of the study and again at weeks 16 and 40 to
measure disease activity and extent of muscle involvement. This will also give an idea
of the response to treatment. This test uses a magnetic field and radio waves to produce
images of body tissues. During the procedure the patient lies on a bed surrounded by a
metal cylinder (the scanner).
- Muscle biopsy at the beginning of the study to diagnose muscle inflammation and again at
week 16 to evaluate the response to treatment.
- Electromyography if the patient has not had an EMG previously. For this test, small
needles are inserted into the muscle to assess the electrical activity of the muscle
- HIV test
Patients whose disease worsen with treatment or who develop serious drug-related side effects
will be taken off the study and referred back to their primary care physician for further
therapy. Patients who improve will be referred back to their primary physician at the end of
the study for possible continued treatment. Participants will be asked to return for
follow-up visits every 6 weeks for a total of 30 weeks to monitor long-term effects of the
drug
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)