Disease-Modifying Treatments for Myasthenia Gravis
NCT03490539 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167
Last updated 2021-02-03
Summary
This study is designed to address the evidence gaps in a real-world setting and help patients with MG choose treatments that are best suited to them. It is a prospective, multicenter observational cohort study of comparative effectiveness of MG treatments, with a patient-centered primary outcome measure, to guide clinicians, patients and payers regarding the choice of treatment options for this chronic and serious disease.
Primary: To compare the effectiveness of azathioprine (AZT) and mycophenolate mofetil (MMF).
Secondary: To compare the outcomes in patients receiving an adequate dose and duration of AZT or MMF over the 2-3 year study period, vs. patients not receiving adequate doses and duration of these agents
Conditions
- Neurological Disorder
- Autoimmune Diseases
Interventions
- DRUG
-
Mycophenolate Mofetil
oral tablets
- DRUG
-
Azathioprine
oral tablet
Sponsors & Collaborators
-
Beth Israel Deaconess Medical Center
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER - lead OTHER
Principal Investigators
-
Jeffery Guptill, MD · Duke University
-
Donald Sanders, MD · Duke University
-
Pushpa Narayanaswami, MD · Beth Israel Deaconess Medical Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-07
- Primary Completion
- 2021-01-31
- Completion
- 2021-01-31
Countries
- United States
- Canada
Study Locations
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