Treatment With TNF Blockade, Infliximab, in Patients With Myositis
An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies
1 other identifier
interventional
N/A
0 countries
N/A
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 persisting muscle weakness and inflammatory active disease despite adequate treatment with immunosuppressives either currently or previously. Infliximab is given as infusions, 5 mg/kg body weight, these infusions are repeated after 2, 6 and 14 weeks. The study involves 15 adult patients. Primary outcome measure is muscle function assessed by muscle function index score. Other outcome measures are Myositis Disease Activity core set: Patient's global assessment and physicians global assessment on visual analogue scales (VAS). Manual muscle test, Health assessment questionnaire (HAQ), serum levels of CPK, LD and extra muscular disease activity score. Muscle biopsy, Magnetic resonance imaging (MRI) of thigh muscles and Health related Quality of life, measured by SF-36.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2007
CompletedFirst Posted
Study publicly available on registry
March 5, 2007
CompletedMarch 5, 2007
March 1, 2007
March 2, 2007
March 2, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Schering-Ploughcollaborator
- Medical Research Councilcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingrid E Lundberg, MD, PhD
Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 2, 2007
First Posted
March 5, 2007
Last Updated
March 5, 2007
Record last verified: 2007-03