Trial Title:
Exploring Outcomes and Characteristics of Myasthenia Gravis 2
NCT ID:
NCT06002945
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Neuromuscular
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Muscle weakness
Autoimmune Diseases
Immune System Diseases
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood sample
Description:
Each blood draw will involve removing approximately 75 mL (5 tablespoons) of blood
Arm group label:
Neurological Outpatients
Summary:
The goal of this prospective observational study is to create a network repository of
clinical data and biological samples to help researchers learn more about myasthenia
gravis.
Detailed description:
The EXPLORE-MG2 (EXPLoring Outcomes and chaRactEristics of Myasthenia Gravis 2) study is
a multi-center natural history study of myasthenia gravis (MG), a rare autoimmune disease
characterized by weakness of the voluntary muscles. MG has a prevalence of approximately
14-40 per 100,000 people in the United States. There is no cure for MG, however,
understanding the disease is crucial to pave the way for development of new therapies and
a deeper mechanistic understanding to improve patient outcomes. Thus, EXPLORE-MG2 aims to
accomplish comprehensive clinical phenotyping linked to bio-specimen collection in an
effort to better understand disease characteristics and identify treatment predictive and
responsive biomarkers. The primary purpose of this project is to create a network
repository of data and biological samples to help researchers learn more about myasthenia
gravis.
Criteria for eligibility:
Study pop:
Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia
Gravis.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Diagnosed with MG based on clinical presentation and seropositivity for MG
associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a
decremental response on repetitive nerve stimulation, positive single fiber
electromyography (EMG) or positive edrophonium test. Signs and symptoms should not
be better explained by another disease process.
- A) Diagnosed with MG within 2 years of study enrollment and with adequate records to
document MG history (e.g., onset, MG meds) prior to enrollment at the discretion of
the investigator.
or B) MuSK antibody, LRP4 antibody, or thymoma-associated MG at any point in the disease
course. Patients with a diagnosis of MG more than 2 years prior to the first study visit
who are expected to undergo a thymectomy may also be enrolled.
- Participant has the capacity to understand and sign a written informed consent form.
- Participant must be willing to complete the study and return for follow-up visits.
Exclusion Criteria:
- A history of chronic degenerative, psychiatric, or neurologic disorder other than MG
that can produce weakness or fatigue that would confound outcome measure assessments
or any disorder that interferes with participation in this protocol.
- Participant is unable or unwilling to comply with the study procedures.
- Treatment with any investigational agent within 4 weeks of the baseline visit or 5
half-lives of the investigational drug (whichever is longer).
1. Participation in other observational studies is not exclusionary
2. It is anticipated that some participants enrolled in EXPLORE-MG2 may be
enrolled in future interventional trials while active in EXPLORE-MG2. This is
acceptable. The exclusion only applies to starting EXPLORE-MG2 when
participation in an interventional trial is imminent or active.
3. If an EXPLORE-MG2 participant is later enrolled in an interventional trial, it
will be at the investigator's discretion whether to continue collecting
biosamples while the patient is participating in the interventional trial.
Collection of natural history data should continue.
- Known active malignancy at enrollment other than skin cancer, low grade prostate
cancer, or cervical cancer in situ. Thymoma is not included in this exclusion
criteria.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates or that may affect the interpretation of the results or render the
participant not an appropriate study participant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California-Irvine
Address:
City:
Irvine
Zip:
92697
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ali Habib, MD
Investigator:
Last name:
Ali Habib, MD
Email:
Principal Investigator
Facility:
Name:
Cedars Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Lewis, MD
Investigator:
Last name:
Richard Lewis, MD
Email:
Principal Investigator
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06519
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bailey Sheldon
Phone:
203-293-0370
Email:
bailey.munrosheldon@yale.edu
Contact backup:
Email:
richard.nowak@yale.edu
Investigator:
Last name:
Richard Nowak, MD, MS
Email:
Principal Investigator
Facility:
Name:
George Washington University
Address:
City:
Washington
Zip:
20037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Henry Kaminski, MD
Investigator:
Last name:
Henry Kaminski, MD
Email:
Principal Investigator
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Betty Soliven, MD
Investigator:
Last name:
Betty Soliven, MD
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amanda Guidon, MD, MPH
Investigator:
Last name:
Amanda Guidon, MD, MPH
Email:
Principal Investigator
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vern Juel, MD
Investigator:
Last name:
Vern Juel, MD
Email:
Principal Investigator
Facility:
Name:
Wake Forest University
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachana Mehta, MD
Investigator:
Last name:
Rachana Mehta, MD
Email:
Principal Investigator
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katherine Ruzhansky, MD
Investigator:
Last name:
Katherine Ruzhansky, MD
Email:
Principal Investigator
Start date:
January 12, 2021
Completion date:
December 2026
Lead sponsor:
Agency:
Yale University
Agency class:
Other
Collaborator:
Agency:
National Center for Advancing Translational Sciences (NCATS)
Agency class:
NIH
Collaborator:
Agency:
National Institute of Neurological Disorders and Stroke (NINDS)
Agency class:
NIH
Source:
Yale University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06002945
