PPDTM CorEvitasTM Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry

Обзор

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.

Подробное описание

The objective of the registry is to create a cohort of myasthenia gravis subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for myasthenia gravis. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of myasthenia gravis, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers.This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence

Первичные конечные точки

• MG epidemiology [Срок оценки: Every 6 months for 10 years]

Критерии участия

Критерии включения

• To be eligible to participate in this registry, an individual must meet all the following criteria:

• Has been diagnosed with myasthenia gravis by a neurologist or a qualified neurology practitioner.
• 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.
• Willing and able to provide informed consent.
• 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.
• In addition, subject must meet at least one of the criteria:

• 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

• 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.

Критерии исключения

• An individual who meets any of the following criteria will be excluded from participation in the registry:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CorEvitas, LLC — Waltham

Идентификаторы

NCT: NCT07217509 · CorEvitas-MGR-720

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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