Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394792
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2022-05-25
Brief Title:
An Observational Study of Upadacitinib to Assess Change in Disease Activity in Canadian Adult Participants With Moderate-to-Severe Atopic Dermatitis Who Are Inadequate Responders To or Discontinuing Dupilumab
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMatitis Patients Who Are Inadequate Responders to Dupilumab or diScontinuing Dupilumab Due to safEtyTolerability Reasons The CAN UpTIMISE Study
Status:
COMPLETED
Status Verified Date:
2024-09
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:
CAN UpTIMISE
Brief Summary:
Atopic dermatitis AD is a skin condition that may cause a rash and itching due to inflammation of the skin Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment This study will assess the real-world effectiveness of upadacitinib on adult participants with moderate-to-severe AD who are inadequate responders to dupilumab or who are discontinuing from dupilumab due to safetytolerability reasons This study also aims to understand upadacitinib utilization patterns in real-world clinical practice
In Canada upadacitinib is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis AD who are not adequately controlled with a systemic treatment eg steroid or biologic or when use of those therapies is inadvisable CAN UpTIMISE will enroll approximately 100 adult participants 18 years of age and above with moderate-to-severe AD who are inadequate responders to dupilumab or are discontinuing from dupilumab from up to 25 sites in Canada
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose population and indication The overall duration of the study is approximately 4 Months
Participants will attend regular visits per routine clinical practice The effect of the treatment will be checked by medical assessments using questionnaires and reporting potential side-effects
In Canada upadacitinib is indicated for the treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis AD who are not adequately controlled with a systemic treatment eg steroid or biologic or when use of those therapies is inadvisable CAN UpTIMISE will enroll approximately 100 adult participants 18 years of age and above with moderate-to-severe AD who are inadequate responders to dupilumab or are discontinuing from dupilumab from up to 25 sites in Canada
Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose population and indication The overall duration of the study is approximately 4 Months
Participants will attend regular visits per routine clinical practice The effect of the treatment will be checked by medical assessments using questionnaires and reporting potential side-effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None