Trials Sponsors Conditions Drugs Pricing

Conditions

Myasthenia Gravis Generalized

Outcome Measures

Primary Outcomes (6)

Identification of Clinical Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Analyze the clinical status of patients comparing the results of MG-ADL clinical scale pre/post FcRn Inhibitors
24 months
Identification of Biological and Cellular Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Analyze the differences between IgG levels pre/post therapy with FcRn inhibitors
24 months
Identification of Biological and Cellular Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
• Evaluate anti-AChR positivity in patients treated with FcRn inhibitors
24 months
Identification of Biological and Cellular Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
• Dosage of proteins involved in pathogenesis
24 months
Identification of Genetic Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Investigate the presence of polymorphisms in the FCGRT gene (VTNRs) in patients refractory to therapy with FcRn inhibitors
24 months
Identification of Clinical Markers of Favorable Response to FcRn Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Analyze the clinical status of patients comparing the results of QMG clinical scale pre/post FcRn Inhibitors
24 months

Secondary Outcomes (1)

Predictive algorithm of favorable response
24 months

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with generalized Myasthenia Gravis positive for anti-AChR antibodies undergoing therapy with FcRn inhibitor drugs

You may qualify if:

\- Age ≥18 years.

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Raffaele Iorio, MD, PhDCONTACT+390630154807 raffaele.iorio@policlinicogemelli.it

Silvia Falso, MDCONTACT+390630154807 falsosilvia@gmail.com

Raffaele Iorio, MDPRINCIPAL INVESTIGATOR

Silvia Falso, MDSUB INVESTIGATOR

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Raffaele Iorio
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffaele Iorio, MD, PhD

CONTACT

+390630154807 raffaele.iorio@policlinicogemelli.it

Silvia Falso, MD

CONTACT

+390630154807

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

November 12, 2024

Study Start

July 9, 2024

Actual (reported)

Primary Completion

July 9, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Markers of Favorable Response to FcRn Inhibitors(INFORM)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Markers of Favorable Response to FcRn Inhibitors(INFORM)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations