Registry of Participants With Generalized Myasthenia Gravis Treated With C5 Inhibition Therapies

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04202341

Collaborator

(none)

500

Enrollment

Locations

59.7

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a long-term, multicenter, observational registry of participants with generalized myasthenia gravis (gMG) who are treated with Alexion complement C5 inhibition therapies (C5IT) prior to enrollment.

Condition or Disease	Intervention/Treatment	Phase
Generalized Myasthenia Gravis

Detailed Description

At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participants' medical history and gMG disease treatment history. Following enrollment, prospective data collection will be performed using data obtained as part of the routine clinical care and through patient-reported outcome methods in use. Data will be collected using an electronic data capture system. The duration of data collection for the Registry will be up to 5 years from the first participant enrolled.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-Term, Observational, Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies

Actual Study Start Date :

Dec 11, 2019

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Outcome Measures

Primary Outcome Measures

Collect Real-world Effectiveness Data In Participants Using Alexion C5IT Therapy [Up to 5 years]

Secondary Outcome Measures

Collect Real-world Data On Other Outcomes Of Interest In Alexion C5IT-treated Participants [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with gMG who have received treatment with Alexion C5IT.
Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions.
Participants must have myasthenia gravis historical data available to be enrolled in the Registry.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Site	Phoenix	Arizona	United States	85001
2	Clinical Trial Site	Fresno	California	United States	93710
3	Clinical Trial Site	Rancho Mirage	California	United States	92270
4	Clinical Trial Site	Clearwater	Florida	United States	33761
5	Clinical Trial Site	Augusta	Georgia	United States	30912
6	Clinical Trial Site	Lake Barrington	Illinois	United States	60010
7	Clinical Trial Site	Las Vegas	Nevada	United States	89145
8	Clinical Trial Site	Durham	North Carolina	United States	27710
9	Clinical Trial Site	Houston	Texas	United States	77001
10	Clinical Trial Site	Burlington	Vermont	United States	05401