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Monoclonal Antibodies

Natalizumab for Inclusion Body Myositis (IBM-NAT Trial)

Phase 1
Waitlist Available
Led By Todd Leveine, MD
Research Sponsored by Phoenix Neurological Associates, LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

IBM-NAT Trial Summary

Muscle biopsies of patients with Inclusion Body Myositis (IBM) have demonstrated a T-cell predominant inflammatory infiltrate, therefore, new agents targeting T -cell mediated cell death may be a novel treatment for IBM. Such an agent capable of preventing T-cell movement out of the vasculature, such as natalizumab, may be beneficial in IBM patients. Six patients will be recruited to participate in this phase I trial.

Eligible Conditions
  • Inclusion Body Myositis

IBM-NAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine if natalizumab is effective and safe in the treatment of patients with IBM (manual muscle testing)
Determine if natalizumab is effective and safe in the treatment of patients with IBM (muscle biopsies)
Secondary outcome measures
Biopsy
measures will involve an assessment of pre and post treatment muscle biopsies including measurements of the degree of inflammation as well as the types of inflammatory cells. (functional rating score scale)
measures will involve an assessment of pre and post treatment muscle biopsies including measurements of the degree of inflammation as well as the types of inflammatory cells. (pain scores)

Side effects data

From 2011 Phase 4 trial • 19 Patients • NCT01144052
70%
Infection
10%
gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Natalizumab
Interferon-beta-1b

IBM-NAT Trial Design

1Treatment groups
Experimental Treatment
Group I: NatalizumabExperimental Treatment1 Intervention
Natalizumab therapy will be given at 300mg intravenously every 4 weeks for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Natalizumab
FDA approved

Find a Location

Who is running the clinical trial?

Phoenix Neurological Associates, LTDLead Sponsor
7 Previous Clinical Trials
218 Total Patients Enrolled
Todd Leveine, MDPrincipal InvestigatorPhoenix Neurological

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Natalizumab in Inclusion Body Myositis (IBM)
2013. "Natalizumab in Inclusion Body Myositis (IBM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02483845.
All > Myositis
~1 spots leftby Apr 2025
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