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Clinical trial

Observational Study to Assess the Effectiveness, Safety Profile and Real-life Prescribing and Utilization Patterns of Tildrakizumab (Ilumetri®) in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice. (SAIL)

ID
Name
NIS Study M-14745-43
Description
The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.
Trial arms
Trial start
2019-10-30
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Active (not recruiting)
Treatment
Tildrakizumab
The study physicians will choose the treatment independently of the enrolment in the study according to routine care.
Arms:
Cohort 1: Tildrakizumab Treated Participants, Cohort 2: Newly Tildrakizumab Prescribed Participants
Size
331
Primary endpoint
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 48
Week 48
Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 96
Week 96
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 48
Baseline (Day 0) and Week 48
Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 96
Baseline (Day 0) and Week 96
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) at Week 48
Week 48
Cohort 1: Correlation Between Absolute Psoriasis Area and Severity Index Scores and Dermatology Life Quality Index adjusted for not relevant responses (DLQI-R) at Week 96
Week 96
Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 48
Week 48
Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 96
Week 96
Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48
Week 48
Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96
Week 96
Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 48
Baseline (Day 0) and Week 48
Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 96
Baseline (Day 0) and Week 96
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48
Week 48
Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96
Week 96
Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 48
Baseline (Day 0) and Week 48
Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 96
Baseline (Day 0) and Week 96
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 52
Week 52
Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 100
Week 100
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 52
Baseline (Week 0) and Week 52
Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 100
Baseline (Week 0) and Week 100
Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 52
Week 52
Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 100
Week 100
Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 52
Week 52
Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 100
Week 100
Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52
Week 52
Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100
Week 100
Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 52
Baseline and Week 52
Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 100
Baseline and Week 100
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 52
Week 52
Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 100
Week 100
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 52
Baseline (Day 0) and Week 52
Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 100
Baseline (Day 0) and Week 100
Eligibility criteria
Inclusion Criteria: * Written informed consent form. * Age \>= 18years. * Moderate to severe chronic plaque psoriasis diagnosis. * Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2). Exclusion Criteria: * Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study. * Participants meeting any of the exclusion criteria specified in the summary of product characteristics (SmPC) of Ilumetri®.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 331, 'type': 'ACTUAL'}}
Updated at
2024-05-08

1 organization

1 product

1 indication

Organization
Almirall
Product
Tildrakizumab
Indication
Psoriasis