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
Atopic DermatitisAtopic 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 safety/tolerability 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 (e.g., 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Able to give written informed consent before starting any study-related assessments
* Diagnosis of moderate or severe AD, as per investigator's judgement
* Initiating upadacitinib treatment, as per the local label, and where decision to treat with upadacitinib must have been made with the participant, prior to and independently of enrolment in the study
* Previous treatment with dupilumab for AD, as the most recent systemic therapy, and who is either or:
* i. sub-optimally controlled as per investigator judgement, after at least 16 weeks of dupilumab treatment, with or without additional AD therapies, at time of baseline visit.
* ii. discontinuing dupilumab due to safety/tolerability reason(s) as per investigator judgement at the baseline visit
* Availability of medication history during the past 4 weeks prior to baseline visit
Exclusion Criteria:
* Previous treatment with any systemic JAKi including upadacitinib, or any investigational drug of chemical or biologic nature within 4 weeks or five half-lives of the drug (whichever is longer) prior to and at the time of the baseline visit
* Currently enrolled in an interventional clinical study, or within the last 30 days or five-half lives of being administered an investigational drug, whichever is longer, prior to baseline visit. Participation in other observational studies or registries is acceptable.
Study Location
Rejuvenation Dermatology - Edmonton Downtown /ID# 246298
Rejuvenation Dermatology - Edmonton Downtown /ID# 246298Edmonton, Alberta
Canada
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Dr. Chih-ho Hong Medical Inc. /ID# 246841
Dr. Chih-ho Hong Medical Inc. /ID# 246841Surrey, British Columbia
Canada
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Allergy Research Canada Inc. /ID# 251916
Allergy Research Canada Inc. /ID# 251916Niagara Falls, Ontario
Canada
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FACET Dermatology /ID# 254914
FACET Dermatology /ID# 254914Toronto, Ontario
Canada
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Clinique D /ID# 247330
Clinique D /ID# 247330Laval, Quebec
Canada
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Dre Angelique Gagne-Henley M.D. inc. /ID# 246457
Dre Angelique Gagne-Henley M.D. inc. /ID# 246457Saint-Jerome, Quebec
Canada
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Rejuvenation Dermatology Clinic Calgary North /ID# 255623
Rejuvenation Dermatology Clinic Calgary North /ID# 255623Calgary, Alberta
Canada
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Alpha Clinic Research Inc. /ID# 248015
Alpha Clinic Research Inc. /ID# 248015Edmonton, Alberta
Canada
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Lynde Institute for Dermatology /ID# 246341
Lynde Institute for Dermatology /ID# 246341Markham, Ontario
Canada
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Canadian Dermatology Centre /ID# 246334
Canadian Dermatology Centre /ID# 246334Toronto, Ontario
Canada
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Dr. Isabelle Delorme Inc. /ID# 246296
Dr. Isabelle Delorme Inc. /ID# 246296Drummondville, Quebec
Canada
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Diex Recherche Québec Inc. /ID# 247696
Diex Recherche Québec Inc. /ID# 247696Québec, Quebec
Canada
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Dermatology Research Institute - Blackfoot Trail /ID# 246344
Dermatology Research Institute - Blackfoot Trail /ID# 246344Calgary, Alberta
Canada
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Stratica Medical /ID# 254940
Stratica Medical /ID# 254940Edmonton, Alberta
Canada
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Nova Scotia Health /ID# 248136
Nova Scotia Health /ID# 248136Halifax, Nova Scotia
Canada
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SKiN Centre for Dermatology /ID# 246291
SKiN Centre for Dermatology /ID# 246291Peterborough, Ontario
Canada
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AvantDerm, Toronto, CA /ID# 250941
AvantDerm, Toronto, CA /ID# 250941Toronto, Ontario
Canada
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Roula Rassi MD Inc /ID# 252563
Roula Rassi MD Inc /ID# 252563Laval, Quebec
Canada
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Sima Recherche inc. /ID# 248338
Sima Recherche inc. /ID# 248338Verdun, Quebec
Canada
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Laser Rejuvenation Clinics Inc. /ID# 255303
Laser Rejuvenation Clinics Inc. /ID# 255303Calgary, Alberta
Canada
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Rejuvaderm /ID# 255850
Rejuvaderm /ID# 255850Edmonton, Alberta
Canada
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Fiona Lovegrove Medicine Professional Corporation /ID# 255784
Fiona Lovegrove Medicine Professional Corporation /ID# 255784London, Ontario
Canada
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York Dermatology Clinic and Research Centre /ID# 246921
York Dermatology Clinic and Research Centre /ID# 246921Richmond Hill, Ontario
Canada
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Evidence based medical educator Inc. /ID# 246687
Evidence based medical educator Inc. /ID# 246687Toronto, Ontario
Canada
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Centre de Recherche St-Louis /ID# 252223
Centre de Recherche St-Louis /ID# 252223Quebec City, Quebec
Canada
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- Study Sponsored By
- AbbVie
- Participants Required
- More Information
- Study ID:
NCT05394792