Identifying markers for response to FcRn inhibitors in myasthenia gravis
Identification of Clinical, Biological, Cellular and Genetic Markers of Favorable Response to Therapy With Neonatal Fc Receptor Inhibitors for Immunoglobulins (FcRn) in Patients With Generalized Myasthenia Gravis (INFORM)
This study is trying to find out which signs can help predict how well FcRn inhibitors will work for adults with generalized myasthenia gravis who have anti-AChR antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06685055 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify markers that predict favorable responses to FcRn inhibitors in patients with generalized myasthenia gravis who are positive for anti-AChR antibodies. It focuses on patients aged 18 and older who require therapy with these inhibitors as per approved indications. The study will involve monitoring patient responses and collecting clinical data to better understand the effectiveness of FcRn inhibitors in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with generalized anti-AChR positive myasthenia gravis who require FcRn inhibitor therapy.
Not a fit: Patients under 18 years old, those with poor compliance to drug therapy, or concurrent autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with myasthenia gravis, improving their outcomes.
How similar studies have performed: While there have been advancements in treatments for myasthenia gravis, this specific approach to identifying response markers for FcRn inhibitors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Age ≥18 years. * Diagnosis of generalized anti-AChR positive Myasthenia Gravis. * Need for therapy with neonatal Fc receptor inhibitors for immunoglobulins (FcRn) as per AIFA-approved therapeutic indications (14). * Ability to follow up at the reference center. * Signed informed consent for the study. Exclusion Criteria: * Age \<18 years. * Poor compliance with drug therapy. * Concurrent autoimmune diseases. * Insufficient availability of clinical information. * Ongoing neoplasm or infection at the time of biological sample collection. * Refusal to sign the informed consent for the study.
Where this trial is running
Rome
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Raffaele Iorio — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Raffaele Iorio, MD, PhD
- Email: raffaele.iorio@policlinicogemelli.it
- Phone: +390630154807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.