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Sponsors and Collaborators: |
Karolinska Institutet Schering-Plough Medical Research Council |
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Information provided by: | Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT00443222 |
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.
Condition | Intervention | Phase |
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Refractory Myositis |
Drug: Infliximab |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Ingrid E Lundberg, MD, PhD | Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden |
Study ID Numbers: | Remicade myositis |
Study First Received: | March 2, 2007 |
Last Updated: | March 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00443222 |
Health Authority: | Sweden: Regional Ethical Review Board |
infliximab polymyositis dermatomyositis inclusion body myositis |
Myositis Dermatomyositis Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Infliximab Myositis, inclusion body Polymyositis Idiopathic myopathy Myositis, Inclusion Body |
Anti-Inflammatory Agents Therapeutic Uses Nervous System Diseases Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |