Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455462
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-01
Brief Title:
Patient Characteristics Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme a Retrospective Observational Medical Chart Review Conducted in UK Severe Asthma Centres
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Patient Characteristics Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme a Retrospective Observational Medical Chart Review Conducted in UK Severe Asthma Centres
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPAP
Brief Summary:
This is a retrospective observational chart review that will include patients with severe asthma SA who have participated in the tezepelumab patient access programme TPAP Electronic case report forms eCRFs will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts
Approximately 200 patients with SA who took part in the TPAP with an index date defined as the date of administration of the first dose of tezepelumab between 1st January 2023 and 19th July 2023 and who meet the study eligibility criteria will be recruited to the study Participation in the study does not affect the patients treatment decisions since all data will be collected retrospectively from medical records Key study definitions include
Index date - the date of tezepelumab initiation ie the date of first dose
Pre-index period - defined as any time prior to tezepelumab initiation
Baseline period - defined as the 52 weeks prior to the index date
Outcomes period - defined as the 52 weeks post-index date
Patients will be followed up from their index date until the first of the following events whichever is first reach 52 weeks post-index they switch to a different biologic treatment die or are otherwise lost to follow-up
Approximately 200 patients with SA who took part in the TPAP with an index date defined as the date of administration of the first dose of tezepelumab between 1st January 2023 and 19th July 2023 and who meet the study eligibility criteria will be recruited to the study Participation in the study does not affect the patients treatment decisions since all data will be collected retrospectively from medical records Key study definitions include
Index date - the date of tezepelumab initiation ie the date of first dose
Pre-index period - defined as any time prior to tezepelumab initiation
Baseline period - defined as the 52 weeks prior to the index date
Outcomes period - defined as the 52 weeks post-index date
Patients will be followed up from their index date until the first of the following events whichever is first reach 52 weeks post-index they switch to a different biologic treatment die or are otherwise lost to follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None