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Nipocalimab for Myasthenia Gravis
Study Summary
This trial will study the effect of nipocalimab on total serum immunoglobulin G (IgG) in children with myasthenia gravis who have not responded well to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My weight and BMI are within the normal range for my age and sex.I use herbal or traditional remedies, supplements, or medical marijuana with my doctor's approval and can keep the dose the same during the study.I have been diagnosed with generalized myasthenia gravis.I had a heart attack, unstable heart disease, or stroke in the last 3 months.I do not have an immunodeficiency unrelated to my myasthenia gravis treatment.I have had or will have surgery to remove my thymus gland within a year.I do not have severe health issues that could affect my study participation or safety.If you are a woman who could become pregnant, you need to have a negative pregnancy test before starting the study.I tested positive for specific antibodies related to my muscle condition.My veins can be used for giving medication and taking blood samples.You have had a serious allergic reaction to therapeutic proteins in the past.
- Group 1: Nipocalimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Why was this clinical trial created?
"The goal of this clinical trial is to observe the changes in Total Serum Immunoglobulin-G (IgG) Antibodies Levels over a period of up to 3 years. Secondary outcomes being assessed include Patient Global Impression of Severity (PGI-S) Score, European Quality of Life 5-Dimension Youth (EQ-5D-Y) Tool Score, and Number of Participants with Neutralizing Antibodies (NAbs) to Nipocalimab."
How many people are allowed to sign up for this experiment?
"That is correct. The information available from clinicaltrials.gov verifies that this trial is still open and looking for participants. 12 patients are needed in total, with the recruitment happening at 11 different hospitals or clinics."
How can I become a subject in this clinical trial?
"This clinical trial is looking for 12 child participants that have been diagnosed with myasthenia gravis. The requirements for enrolment are as follows: A positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening, A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study, Has"
Is this research being conducted in more than one location within the city limits?
"Currently, this study has 11 enrolling patients from locations such as University of South Florida Morsani Center for Advanced Healthcare in Tampa, University of Kansas Medical Center in Lawrence, Lucile Packard Children's Hospital Stanford in Palo Alto, and 11 other centres."
Does this research include elderly patients in its population sample?
"Eligibility for this trial requires that patients are aged 2-17. Out of the 84 clinical trials, 72 are for people older than 65 and 12 are specifically designed for those under 18."
Are new volunteers being enrolled in this experiment at present?
"That is correct. According to the information on clinicaltrials.gov, this study was originally posted on 7/20/2022 and is presently looking for 12 participants that meet specific criteria from 11 locations."
Who else is applying?
What portion of applicants met pre-screening criteria?
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