Status:
COMPLETED
Treatment With TNF Blockade, Infliximab, in Patients With Myositis
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Schering-Plough
Medical Research Council
Conditions:
Refractory Myositis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a 4 month open trial with TNF-blockade using infliximab (an antibody that blocks TNF) in adult patients with chronic myositis (polymyositis, dermatomyositis, inclusion body myositis) who have ...
Eligibility Criteria
Inclusion
- Adult patients.
- Persisting muscle weakness defined as ≤ 80% of muscle strength as measured by functional index of myositis
- Signs of disease activity defined as muscle edema observed by magnetic resonance imaging (MRI) or creatine kinase (CK) elevation, or inflammatory cell infiltrates on muscle biopsy, and failure to respond to treatment with glucocorticoids for a minimum of six months in combination with azathioprine or methotrexate.
Exclusion
- Pregnant women, nursing mothers or a planned pregnancy within one and a half years of enrolment.
- Prior administration of infliximab or any other therapeutic agent targeted at reducing TNF (e.g., Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous six months.
- A history of known allergies to murine proteins.
- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection (colds) or uncomplicated urinary tract infection need not to considered exclusions at the discretion of the treating physician.
- History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active pneumocystis carinii, drug resistant atypical mycobacterium, etc.
- Documented HIV infection.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years.
- Patients with alcoholism, alcoholic liver disease, or other chronic liver disease.
- Patients with a positive PPD and chest X-Ray suggestive of active TB or a previous exposure to TB.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00443222
Last Update
March 5 2007
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