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Treatment With TNF Blockade, Infliximab, in Patients With Myositis

NCT00443222 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2007-03-05

No results posted yet for this study

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.

Conditions

  • Refractory Myositis

Interventions

DRUG

Infliximab

Sponsors & Collaborators

Principal Investigators

  • Ingrid E Lundberg, MD, PhD · Rheumatology Unit, Department of Medicine, Karolinska University Hospital, Solna, Karolinska Institutet, Stockholm, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443222 on ClinicalTrials.gov