NUCALA® Special Drug Use Investigation (EGPA, Long-term)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Treatments: Drug: Nucala

Study type: Observational

Funder types: Industry

Identifiers

NCT03557060

208505

Details and patient eligibility

About

This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.

Enrollment: 4,115 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included.
• Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period

Exclusion criteria

• Not applicable.

Trial design

4,115 participants in 1 patient group

Subjects receiving NUCALA

Description:

Subjects with a diagnosis of EPGA, for which NUCALA is indicated will be included.

Treatment:

Drug: Nucala