Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000478

EU PAS number

EUPAS1000000478

Study ID

1000000478

Official title and acronym

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

DARWIN EU® study

Yes

Study countries

Austria
Canada
China
France
Germany
Greece
Italy
Kuwait
Saudi Arabia
Türkiye
United Arab Emirates
United States

Study description

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®).

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 day of enrollment.

Study status

Ongoing
Research institutions and networks

Institutions

Alexion Pharmaceuticals, Inc.

Contact details

N/A N/A

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol

ECU-MG-501 protocol final 10Jul2019(2)_signed.pdf

English (367.79 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable