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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02483845 |
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Date of registration:
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31/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Natalizumab in Inclusion Body Myositis (IBM)
IBM-NAT |
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Scientific title:
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Pilot Study of Natalizumab in the Treatment of Patients With Inclusion Body Myositis |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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6 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02483845 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Todd Leveine, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Phoenix Neurological |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Inclusion Body Myositis (IBM)
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Intervention(s)
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Drug: Natalizumab
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Primary Outcome(s)
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Determine if natalizumab is effective and safe in the treatment of patients with IBM (manual muscle testing)
[Time Frame: 12 months]
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Determine if natalizumab is effective and safe in the treatment of patients with IBM (muscle biopsies)
[Time Frame: 12 months]
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Secondary Outcome(s)
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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)
[Time Frame: 12 months]
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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)
[Time Frame: 12 months]
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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)
[Time Frame: 12 months]
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Secondary ID(s)
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IBM-2013
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117571
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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