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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04053881
Other study ID # PS0026
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 21, 2019
Est. completion date December 2, 2022

Study information

Verified date January 2023
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 412
Est. completion date December 2, 2022
Est. primary completion date December 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patient is =18 years of age at observational point 1 - The patient must have a clinical diagnosis of moderate to severe Plaque psoriasis according to the diagnostic criteria used by the physician in routine clinical practice - The patient has an available PASI assessment prior to the first certolizumab pegol dose according to the standard of care - The patient must be newly prescribed with certolizumab pegol - If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study Exclusion Criteria: Not applicable

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Certolizumab pegol
Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection

Locations

Country Name City State
Belgium Ps0026 103 Brussels
Belgium Ps0026 101 Bruxelles
Belgium Ps0026 107 Bruxelles
Belgium Ps0026 102 Leuven
Belgium Ps0026 110 Maldegem
Belgium Ps0026 109 Mons
Belgium Ps0026 104 Namur
Canada Ps0026 208 London
Canada Ps0026 209 London
Canada Ps0026 201 Markham
Canada Ps0026 210 Newmarket
Canada Ps0026 203 St- John's
Canada Ps0026 212 Toronto
Canada Ps0026 205 Waterloo
Canada Ps0026 204 Winnipeg
Czechia Ps0026 303 Praha 1
Czechia Ps0026 301 Praha 5
Czechia Ps0026 302 Uherske Hradiste
France Ps0026 408 Amiens Cedex
France Ps0026 404 Lorient
France Ps0026 409 Poitiers
France Ps0026 403 Rennes
France Ps0026 407 Toulon
Germany Ps0026 512 Bielefeld
Germany Ps0026 532 Bogen
Germany Ps0026 525 Dresden
Germany Ps0026 506 Düren
Germany Ps0026 521 Freiburg
Germany Ps0026 529 Gladbeck
Germany Ps0026 523 Hamburg
Germany Ps0026 518 Karlsruhe
Germany Ps0026 519 Leipzig
Germany Ps0026 537 Magdeburg
Germany Ps0026 530 Memmingen
Germany Ps0026 516 Merzig
Germany Ps0026 517 München
Germany Ps0026 527 München
Germany Ps0026 515 Nürnberg
Germany Ps0026 501 Potsdam
Germany Ps0026 511 Quedlinburg
Germany Ps0026 505 Remscheid
Greece Ps0026 603 Athens
Greece Ps0026 609 Athens
Greece Ps0026 610 Athens
Greece Ps0026 601 Chaidari
Greece Ps0026 606 Larissa
Greece Ps0026 608 Patras
Greece Ps0026 607 Pireas
Greece Ps0026 604 Thessaloniki
Greece Ps0026 605 Thessaloniki
Italy Ps0026 707 Bari
Italy Ps0026 714 Bologna
Italy Ps0026 711 Brescia
Italy Ps0026 712 Catania
Italy Ps0026 710 Firenze
Italy Ps0026 702 Genova
Italy Ps0026 706 L'aquila
Italy Ps0026 701 Napoli
Italy Ps0026 709 Roma
Italy Ps0026 713 Roma
Italy Ps0026 704 San Donato Milanese
Italy Ps0026 715 Torino
Italy Ps0026 708 Torrette DI Ancona
Spain Ps0026 807 Badalona
Spain Ps0026 809 Barcelona
Spain Ps0026 812 Barcelona
Spain Ps0026 804 Pontevedra
Spain Ps0026 806 Sant Joan Despí
Spain Ps0026 818 Vigo
United Kingdom Ps0026 902 Bradford
United Kingdom Ps0026 909 Dunfermline
United Kingdom Ps0026 914 Glasgow
United Kingdom Ps0026 916 Hertfordshire
United Kingdom Ps0026 911 Kingston Upon Thames
United Kingdom Ps0026 905 Leeds
United Kingdom Ps0026 904 Newcastle Upon Tyne
United Kingdom Ps0026 901 Salford
United Kingdom Ps0026 915 Wakefield
United Kingdom Ps0026 908 York

Sponsors (1)

Lead Sponsor Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

Belgium,  Canada,  Czechia,  France,  Germany,  Greece,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2 The Psoriasis Area Severity Index (PASI75) response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions with a score of 0 (clear) to 4 (very marked). From Baseline up to Week 21
Secondary Change from Baseline in Dermatology Life Quality Index score at observational point 2 The Dermatology Life Quality Index (DLQI) consists of questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI score ranges from 0 to 30 with higher scores indicating lower health-related quality of life (HRQoL). From Baseline up to Week 21
Secondary Change from Baseline in Dermatology Life Quality Index score at observational point 4 The Dermatology Life Quality Index (DLQI) consists of questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI score ranges from 0 to 30 with higher scores indicating lower health-related quality of life (HRQoL). From Baseline up to Week 56
Secondary Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4 The Psoriasis Area Severity Index (PASI75) response assessments are based on at least 75 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions with a score of 0 (clear) to 4 (very marked). From Baseline up to Week 56
Secondary Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2 The Psoriasis Area Severity Index (PASI90) response assessments are based on at least 90 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions with a score of 0 (clear) to 4 (very marked). From Baseline up to Week 21
Secondary Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4 The Psoriasis Area Severity Index (PASI90) response assessments are based on at least 90 % improvement in the PASI score from Baseline. The PASI score is a measure of the average redness, thickness, and scaliness of the psoriatic skin lesions with a score of 0 (clear) to 4 (very marked). From Baseline up to Week 56
See also
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