Clinical trial · Observational
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
NCT06298565CI-TRIAL-00103341recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| efgartigimod | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- efgartigimod cohort
- description
- patients treated with efgartigimod
- interventionNames
- Biological: efgartigimod
- label
- non-efgartigimod cohort
- description
- patient treated with other MG medication
Primary outcomes (1)
- measure
- 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
- timeFrame
- up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.