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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03557060
Date of registration: 04/06/2018
Prospective Registration: Yes
Primary sponsor: GlaxoSmithKline
Public title: NUCALA® Special Drug Use Investigation (EGPA, Long-term)
Scientific title: NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term)
Date of first enrolment: June 25, 2018
Target sample size: 300
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03557060
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Japan
Contacts
Name:     GSK Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  GlaxoSmithKline
Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Churg-Strauss Syndrome
Intervention(s)
Drug: Nucala
Primary Outcome(s)
Incidence of adverse drug reactions [Time Frame: Up to 2 years]
Response rate based on global assessment of effectiveness [Time Frame: Up to 2 years]
Time to EGPA remission and recurrence [Time Frame: Up to 2 years]
Secondary Outcome(s)
Secondary ID(s)
208505
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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