Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period.
Official Title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab as Monotherapy or in Addition to Baseline Therapy in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD)
Quick Facts
Study Start:2022-08-30
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
Mayo Clinic- Scottsdale
Scottsdale, Arizona, 85259
United States
University of California Irvine - Manchester Pavilion
Orange, California, 92868
United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, 80045
United States
Medstar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
University of Florida College of Medicine Gainesville
Gainesville, Florida, 32608
United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, 32207
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
Northwestern University
Chicago, Illinois, 60611
United States
Consultants in Neurology Ltd
Northbrook, Illinois, 60062
United States
Johns Hopkins
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso, Michigan, 48867
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55902
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
NYU Langone
New York, New York, 10003
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44915
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
Premier Neurology
Greenville, South Carolina, 29605
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Collaborators and Investigators
Sponsor: Hoffmann-La Roche
- Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2022-08-30
Study Completion Date2028-12-31
Study Record Updates
Study Start Date2022-08-30
Study Completion Date2028-12-31
Terms related to this study
Additional Relevant MeSH Terms
- Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)