DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Natalizumab in Inclusion Body Myositis (IBM)

Information source: Phoenix Neurological Associates, LTD
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inclusion Body Myositis (IBM)

Intervention: Natalizumab (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Phoenix Neurological Associates, LTD

Official(s) and/or principal investigator(s):
Todd Leveine, MD, Principal Investigator, Affiliation: Phoenix Neurological

Overall contact:
Lynne Flynn, CCRC, Phone: 602-258-2863, Email: lynneflynn@pnal.net

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.

Clinical Details

Official title: Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body Myositis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Determine if natalizumab is effective and safe in the treatment of patients with IBM (muscle biopsies)

Determine if natalizumab is effective and safe in the treatment of patients with IBM (manual muscle testing)

Secondary outcome:

Secondary outcome 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. (blood levels)

Secondary outcome 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)

Secondary outcome 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)

Detailed description: This is a phase I open label, non-placebo controlled trial evaluating the safety and efficacy of natalizumab in patients with IBM. Pre and post treatment muscle biopsies including measurements of the degree of inflammation as well as the types of inflammatory cells will be measured. The investigators will also assess quality of life, the inclusion body myositis functional rating score (IBM-FRS), and patient and physician global impression of change. Manual muscle testing and quantitative dynamometry will also be evaluated to see if patient's strength improves. Patients who are eligible to participate and have signed a consent form will have a muscle biopsy performed at baseline and at the end of the study. Physical and neurological exams, as well as IBM-FRS, safety labs will be conducted and collected at monthly visits. Patients will start natalizumab therapy at 300mg intravenously every 4 weeks for 24 weeks. All study related procedures will be conducted at Phoenix Neurological Associates, as well as all infusions and muscle biopsies

Eligibility

Minimum age: 21 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Lynne Flynn, CCRC, Phone: 602-258-2863, Email: lynneflynn@pnal.net

Phoenix Neurological Insitutute, Phoenix, Arizona 85018, United States; Recruiting
Lynne Flynn, CCRC, Phone: 602-258-2863, Email: lynne.flynn@pnal.net
Todd D Levine, MD, Principal Investigator
David S Saperstein, MD, Sub-Investigator
Additional Information

Starting date: May 2013
Last updated: June 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017