Natalizumab in Inclusion Body Myositis (IBM)

• Status: Unknown status
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Neurological Associates, LTD
• Treatments: Natalizumab

Criteria

Inclusion Criteria:

1. Definite diagnosis of sporadic IBM through previous muscle biopsies

2. Age 21-85

3. FVC> 50%

4. Muscle function adequate for quantitative muscle testing

5. JC virus negative at screening

Exclusion Criteria:

1. Previous therapy with natalizumab.

2. Treatment with other immunosuppressive agents within the last 12 months

3. Quadriceps strength less than or equal to 2/5 at baseline

4. Known malignancy

5. Pregnancy or breastfeeding

6. History of abnormal laboratory results indicative of any significant medical disease that would preclude the use of natalizumab

7. Any clinically significant infectious illness in the 30 days before enrollment