Clinical trial NCT04203693: Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Ilumetri®
Tildrakizumab
Moderate to severe plaque psoriasis
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients with moderate-to-severe chronic plaque psoriasis.

Brief summary: 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.


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®.

Primary outcomes:
measure: Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 48
timeFrame: Week 48
measure: Cohort 1: Absolute Psoriasis Area and Severity Index (PASI) at Week 96
timeFrame: Week 96
measure: Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 48
timeFrame: Baseline (Day 0) and Week 48
measure: Cohort 1: Change From Baseline in Psoriasis Area and Severity Index at Week 96
timeFrame: Baseline (Day 0) and Week 96
measure: 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
timeFrame: Week 48
measure: 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
timeFrame: Week 96
measure: Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 48
timeFrame: Week 48
measure: Cohort 1: Percentage of Participants who maintaining Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 96
timeFrame: Week 96
measure: Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 48
timeFrame: Week 48
measure: Cohort 1: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 96
timeFrame: Week 96
measure: Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 48
timeFrame: Baseline (Day 0) and Week 48
measure: Cohort 1: Change from Baseline in Body Surface Area Affected by Psoriasis at Week 96
timeFrame: Baseline (Day 0) and Week 96
measure: Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 48
timeFrame: Week 48
measure: Cohort 1: Absolute Physician's Global Assessment (PGA) (General, Nail, Scalp) Scores at Week 96
timeFrame: Week 96
measure: Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 48
timeFrame: Baseline (Day 0) and Week 48
measure: Cohort 1: Change From Baseline in Physician's Global Assessment (PGA) (General, Nail, Scalp) at Week 96
timeFrame: Baseline (Day 0) and Week 96
measure: Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 52
timeFrame: Week 52
measure: Cohort 2: Absolute Psoriasis Area and Severity Index (PASI) at Week 100
timeFrame: Week 100
measure: Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 52
timeFrame: Baseline (Week 0) and Week 52
measure: Cohort 2: Change From Baseline in Psoriasis Area and Severity Index at Week 100
timeFrame: Baseline (Week 0) and Week 100
measure: Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 52
timeFrame: Week 52
measure: Cohort 2: Correlation between absolute Psoriasis Area and Severity Index scores and Dermatology Life Quality Index adjusted for not relevant responses at Week 100
timeFrame: Week 100
measure: Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 52
timeFrame: Week 52
measure: Cohort 2: Percentage of Participants who Achieved Psoriasis Area and Severity Index 75, 90, and 100 Responses at Week 100
timeFrame: Week 100
measure: Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 52
timeFrame: Week 52
measure: Cohort 2: Absolute Body Surface Area Affected by Psoriasis (BSA) at Week 100
timeFrame: Week 100
measure: Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 52
timeFrame: Baseline and Week 52
measure: Cohort 2: Change from Baseline in Percent Body Surface Area Affected by Psoriasis (BSA) at Week 100
timeFrame: Baseline and Week 100
measure: Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 52
timeFrame: Week 52
measure: Cohort 2: Absolute Physician's Global Assessment (PGA) (General, Nail and Scalp) at Week 100
timeFrame: Week 100
measure: Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 52
timeFrame: Baseline (Day 0) and Week 52
measure: Cohort 2: Change From Baseline in Physician's Global Assessment (PGA) (Scores of General, Nail and Scalp) at Week 100
timeFrame: Baseline (Day 0) and Week 100
Secondary outcomes:
measure: Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
timeFrame: Cohort 1: Week 48 and Week 96; Cohort 2: Week 52 and Week 100
measure: Change from Baseline in Absolute Dermatology Life Quality Index and Dermatology Life Quality Index Adjusted for not Relevant Responses at Week 48 and Week 96 for Cohort 1 and Week 52 and Week 100 for Cohort 2
timeFrame: Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100
measure: Itch and Pain Visual Analogue Scales (VAS) Scores
timeFrame: Baseline (Day 0) to Week 96/100
measure: Change from Baseline in Itch and Pain Visual Analogue Scales Scores
timeFrame: Baseline (Day 0) to Week 96/100
measure: Number of participants who Used Concomitant Medications From Baseline at Week 48 and 96 for Cohort 1 and Week 52 and 100 for Cohort 2
timeFrame: Cohort 1: Baseline (Day 0), Week 48 and Week 96; Cohort 2: Baseline, Week 52 and Week 100
measure: Change from Baseline in Body Weight at End of study (EOS)/End of treatment (ET)
timeFrame: Baseline (Day 0) and Week 96/100 (EOS)/ET
measure: Change from Baseline in Waist and hip Circumference at EOS/ET
timeFrame: Baseline (Day 0) and Week 96/100 (EOS)/ET
measure: Change from Baseline in Body Mass Index (BMI) at EOS/ET
timeFrame: Baseline (Day 0) and Week 96/100 (EOS)/ET
measure: Change from Baseline in Blood Pressure at EOS/ET
timeFrame: Baseline (Day 0) and Week 96/100 (EOS)/ET
measure: Change from Baseline in Food Intake up to EOS/ET
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)/ET
measure: Change from Baseline in Physical Activity up to EOS/ET
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)/ET
measure: Change from baseline in Lipid Profiles up to EOS
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)
measure: Number of Participants Withdraw From the Study Overtime
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)
measure: Number of Participants who Underwent Dose Change up to EOS/ET
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)/ET
measure: Drug Survival up to EOS/ET
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)/ET
measure: Number of Participant's With Adherence to Treatment up to EOS/ET
timeFrame: Baseline (Day 0) to Week 96/100 (EOS)/ET
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Investigator Site 1
city: Augsburg
country: Germany
facility: Investigational site 5
city: Berlin
country: Germany
facility: Investigational site 10
city: Berlin
country: Germany
facility: Investigational site 11
city: Berlin
country: Germany
facility: Investigational site 13
city: Erlangen
country: Germany
facility: Investigational site 8
city: Greifswald
country: Germany
facility: Investigational site 9
city: Hamburg
country: Germany
facility: Investigational site 1
city: Hamburg
country: Germany
facility: Investigational site 2
city: Kiel
country: Germany
facility: Investigational site 7
city: Lübeck
country: Germany
facility: Investigational site 3
city: München
country: Germany
facility: Investigational site 6
city: Oberursel
country: Germany
facility: Investigational site 12
city: Quedlinburg
country: Germany
facility: Investigational site 4
city: Catania
country: Italy
facility: Investigational site 6
city: Genova
country: Italy
facility: Investigational site 7
city: Modena
country: Italy
facility: Investigational site 3
city: Parma
country: Italy
facility: Investigational site 4
city: Roma
country: Italy
facility: Investigational site 1
city: Roma
country: Italy
facility: Investigational site 2
city: Roma
country: Italy
facility: Investigational site 5
city: Breda
country: Netherlands
facility: Investigational site 1
Study officials:
affiliation: Almirall, S.A.
name: Study Director
role: STUDY_DIRECTOR
References: