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

Churg-Strauss Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03557060
• Other study ID #: 208505
• Status: Active, not recruiting
• Start date: June 25, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Churg-Strauss Syndrome

Intervention

Drug:
• Nucala
NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse drug reactions	The information regarding the incidences of adverse drug reactions will be collected.	Up to 2 years
Primary	Response rate based on global assessment of effectiveness	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.	Up to 2 years
Primary	Time to EGPA remission and recurrence	The time to EGPA remission and recurrence will be assessed.	Up to 2 years