Clinical Trials Logo
  1. Home
  2. Myasthenia Gravis
  3. NCT06298565
  4. Details
NCT06298565 Clinical Trial

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Myasthenia Gravis Clinical Trial

Official title:
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06298565
Other study ID # ARGX-113-PASS-2208
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2034

Study information
Verified date March 2024
Source argenx
Contact Sabine Coppieters, MD
Phone 857-350-4834
Email Clinicaltrials@argenx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 680
Est. completion date June 2034
Est. primary completion date June 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment - Have provided appropriate written informed consent Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• efgartigimod
efgartigimod

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
argenx

Outcome
Type Measure Description Time frame Safety issue
Primary The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod up to 10 years
See also
  Status Clinical Trial Phase
Completed NCT05039190 - Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients Phase 3
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT01727193 - The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy Phase 3
Completed NCT00285350 - Mycophenolate Mofetil in Myasthenia Gravis Phase 3
Recruiting NCT05890833 - The Risk of Falls Index for Patients With Neuromuscular Disorders
Completed NCT05694234 - Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Not yet recruiting NCT04965987 - Oxaloacetate in Myasthenia Gravis Phase 1
Not yet recruiting NCT05095103 - Immune Profiles in Myasthenia Gravis
Terminated NCT02102594 - Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) Phase 2
Completed NCT02066519 - Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis N/A
Completed NCT02774239 - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) Phase 3
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Terminated NCT01828294 - Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis Phase 1
Terminated NCT00727194 - Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT04590716 - Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Recruiting NCT04837625 - Study of Myasthenic Crisis in China
Not yet recruiting NCT01469858 - Perception and Multisensory Integration in Neurological Patients Using fMRI N/A
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Completed NCT03205306 - Myasthenia Gravis and Psyche