NCT04202341 Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)
| NCT ID | NCT04202341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Generalized Myasthenia Gravis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-12-02 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2019-12-02 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).
Eligibility Criteria
Inclusion Criteria: 1. Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. 2. Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions. 3. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFA class, available to be enrolled in the Registry. Exclusion Criteria: 1\. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04202341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04202341 currently recruiting?
Yes, NCT04202341 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT04202341 trial being conducted?
This trial is being conducted at Birmingham, United States, Scottsdale, United States, Fresno, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT04202341 clinical trial?
NCT04202341 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 500 participants.