Clinical trial · Observational
PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry
NCT07217509CI-TRIAL-00124171enrolling by invitationClinicalTrials.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)
The design is a prospective, observational (non-interventional) registry for subjects with myasthenia gravis under the care of a neurology provider. Longitudinal data are collected from both subjects and their treating neurology provider during routine clinical encounters using a structured and standardized data collection method. Approximately 1,500 myasthenia gravis subjects with no defined upper limit and 50 clinical neurology sites will be recruited.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MG epidemiology
- timeFrame
- Every 6 months for 10 years
- description
- The major clinical outcome include an assessment of the epidemiology of Myasthenia Gravis; to better understand the presentation and natural history. This will be determined using PROs and ClinROs which will be included as part of the case report forms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* To be eligible to participate in this registry, an individual must meet all the following criteria:
1. Has been diagnosed with myasthenia gravis by a neurologist or a qualified neurology practitioner.
2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
3. Willing and able to provide informed consent.
4. Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, home address zip/postal code and email address or phone Number at a minimum) if required based on registry location and applicable laws and regulations.
5. In addition, subject must meet at least one of the criteria:
1. Have started taking a new Enrollment Eligible Medication within 12 months prior to the Enrollment visit. A new medication is a medication that the subject has never taken before.
OR
2. Is initiating (prescribed or starting) a new Enrollment Eligible Medication at the Enrollment visit. A new medication is a medication that the subject has never taken before.
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in the registry:
1. Is participating or planning to participate in a double-blind clinical trial for a myasthenia gravis drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.References
Publications (0)
Data not yet available
No reference posted for this study.