Treatment With TNF Blockade, Infliximab, in Patients With Myositis
|ClinicalTrials.gov Identifier: NCT00443222|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 5, 2007
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 or disease||Intervention/treatment||Phase|
|Refractory Myositis||Drug: Infliximab||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Trial With TNF Blockade With Infliximab (Remicade®), in Patients With Chronic Inflammatory Myopathies|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443222
|Principal Investigator:||Ingrid E Lundberg, MD, PhD||Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden|