RECRUITING

Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)

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Conditions

Generalized Myasthenia GravisgMGSolirisUltomirisAlexion C5 Inhibition TherapyAlexion C5ITPatient RegistryAlexion Registry

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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

Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).

Official Title

Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)

Quick Facts

Study Start:2019-12-02
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04202341

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment.
  2. 2. Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions.
  3. 3. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFA class, available to be enrolled in the Registry.
  1. 1. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Clinical Trial Site
Birmingham, Alabama, 35294
United States
Clinical Trial Site
Scottsdale, Arizona, 85251
United States
Clinical Trial Site
Fresno, California, 93710
United States
Clinical Trial Site
Orange, California, 92868
United States
Clinical Trial Site
Rancho Mirage, California, 92270
United States
Clinical Trial Site
Sylmar, California, 91342
United States
Clinical Trial Site
Colorado Springs, Colorado, 80907
United States
Clinical Trial Site
Fort Collins, Colorado, 80528
United States
Clinical Trial Site
New Haven, Connecticut, 06520
United States
Clinical Trial Site
Washington, District of Columbia, 10010
United States
Clinical Trial Site
Clearwater, Florida, 33761
United States
Clincal Trial Site
Gainesville, Florida, 32608
United States
Clinical Trial Site
Jacksonville, Florida, 32209
United States
Clinical Trial Site
Tampa, Florida, 33612
United States
Clinical Trial Site
Augusta, Georgia, 30912
United States
Clinical Trial Site
Iowa City, Iowa, 52242
United States
Clinical Trial Site
Lexington, Kentucky, 40503
United States
Clinical Trial Site
Boston, Massachusetts, 02215
United States
Clinical Trial Site
Lansing, Michigan, 48824
United States
Clinical Trial Site
Columbia, Missouri, 65212
United States
Clinical Trial Site
New Hyde Park, New York, 11042
United States
Clinical Trial Site
Chapel Hill, North Carolina, 27599
United States
Clinical Trial Site
Charlotte, North Carolina, 28207
United States
Clinical Trial Site
Durham, North Carolina, 27705
United States
Clinical Trial Site
Dayton, Ohio, 45459
United States
Clinical Trial Site
Philadelphia, Pennsylvania, 19104
United States
Clinical Trial Site
Chattanooga, Tennessee, 37403
United States
Clinical Trial Site
Knoxville, Tennessee, 37920
United States
Clinical Trial Site
Dallas, Texas, 75206
United States
Clinical Trial Site
Houston, Texas, 77030
United States
Clinical Trial Site
Burlington, Vermont, 05401
United States
Clinical Trial Site
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

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 Date2019-12-02
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2019-12-02
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • gMG
  • Soliris
  • Ultomiris
  • Alexion C5 Inhibition Therapy
  • Alexion C5IT
  • Patient Registry
  • Generalized Myasthenia Gravis
  • Alexion Registry

Additional Relevant MeSH Terms

  • Generalized Myasthenia Gravis