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

• Conditions: Churg-Strauss Syndrome
• Interventions: Drug: Nucala

• Registration Number: NCT03557060
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-14
• Study Start: 2018-06-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

• Not applicable.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects receiving NUCALA	Nucala	Subjects with a diagnosis of EPGA, for which NUCALA is indicated will be included.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	Up to 2 years	The information regarding the incidences of adverse drug reactions will be collected.
Response rate based on global assessment of effectiveness	Up to 2 years	The response rate is the percentage of subjects assessed as effective. Effectiveness will be comprehensively assessed by any of effective or not effective at Week 12, 48 after the start of NUCALA administration, end of the observation period, or withdrawal/termination, based on the course of subjective symptoms, course of clinical symptoms, from the start date of administration to the end of the observation period. If effectiveness cannot be determined for some reasons, it should be assessed as indeterminable and its reasons should be recorded on the CRF.
Time to EGPA remission and recurrence	Up to 2 years	The time to EGPA remission and recurrence will be assessed.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan