Status:
UNKNOWN
A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of Natalizumab
Lead Sponsor:
Berkovich, Regina MD, PhD Inc.
Collaborating Sponsors:
Biogen
Cedars-Sinai Medical Center
Conditions:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief Summary
This is an open-label study of patients with relapsing forms of MS is designed to assess the biochemical, immunological, and kinetic profiles of natalizumab being used with specific brief dosing inter...
Detailed Description
Study Title: The impact of a planned 12-week dosing interruption of natalizumab on immune cell trafficking, PK/PD parameters, and MS disease stability. Objectives: Hypothesis: An interruption in th...
Eligibility Criteria
Inclusion
- To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of randomization:
- Screening Visit:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- At least 18 years old at the time of informed consent.
- Must be a patient with a relapsing form of Multiple Sclerosis enrolled in the TOUCH Prescribing Program who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study.
- Must weigh between 50 and 110 kg, inclusive.
- Patients must be considered clinically stable and scheduled for their pre-planned annual dose interruption of 2 consecutive skipped doses.
- No evidence of disease activity with on standard (28-day interval) dosing of natalizumab.
Exclusion
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- Medical History
- If subject answers 'Yes" to any question on the PML questionnaire that is not resolved prior to infusion as per standard operating procedure for natalizumab infusion.
- If subject consumes alcohol within 24 hours of blood specimen collection.
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04048577
Start Date
July 3 2019
End Date
December 1 2021
Last Update
July 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Regina Berkovich MD, PhD Inc.
West Hollywood, California, United States, 90048