Natalizumab in Inclusion Body Myositis (IBM)

Status unconfirmed · Phase 1

Conditions studied: Inclusion Body Myositis (IBM)

In brief

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.

Key facts

Study ID

NCT02483845

Run by

Phoenix Neurological Associates, LTD

People needed

6

Starts

2013-05-01

Expected to finish

2017-11-01

Last updated by the study team

2017-02-09

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Definite diagnosis of sporadic IBM through previous muscle biopsies
• Age 21-85
• FVC> 50%
• Muscle function adequate for quantitative muscle testing
• JC virus negative at screening

You may not qualify if…

• Previous therapy with natalizumab.
• Treatment with other immunosuppressive agents within the last 12 months
• Quadriceps strength less than or equal to 2/5 at baseline
• Known malignancy
• Pregnancy or breastfeeding
• History of abnormal laboratory results indicative of any significant medical disease that would preclude the use of natalizumab
• Any clinically significant infectious illness in the 30 days before enrollment

Where it is running

• Phoenix Neurological Insitutute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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