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BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
Phase 2
Waitlist Available
Led By Richard J Nowak, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks prior baseline and 4 weeks prior to week 52
Awards & highlights
All Individual Drugs Already Approved
Summary
The specific primary objective of this study is to determine whether rituximab is a safe and beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III efficacy trial.
Eligible Conditions
- Myasthenia Gravis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks prior baseline and 4 weeks prior to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks prior baseline and 4 weeks prior to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety:Percentage of Study Participants With Treatment-related Adverse Experiences
Steroid Sparing Effect
Secondary study objectives
Change in Myasthenia Gravis Composite (MGC) Scores From Baseline to Week 52
Change in Quantitative Myasthenia Gravis(QMG) Scores From Baseline to Week 52
Side effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RituximabExperimental Treatment1 Intervention
Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks
Group II: PlaceboPlacebo Group1 Intervention
The placebo group will receive a vehicle control infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,422 Total Patients Enrolled
3 Trials studying Myasthenia Gravis
1,252 Patients Enrolled for Myasthenia Gravis
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,636 Total Patients Enrolled
4 Trials studying Myasthenia Gravis
610 Patients Enrolled for Myasthenia Gravis
Richard J Nowak, MD, MSPrincipal InvestigatorYale University
1 Previous Clinical Trials
31 Total Patients Enrolled