Clinical trial NCT04053881: A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice
Official title: A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Plaque psoriasis
Cimzia
Certolizumab pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2
timeFrame: From Baseline up to Week 21
Secondary outcomes:
measure: Change from Baseline in Dermatology Life Quality Index score at observational point 2
timeFrame: From Baseline up to Week 21
measure: Change from Baseline in Dermatology Life Quality Index score at observational point 4
timeFrame: From Baseline up to Week 56
measure: Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4
timeFrame: From Baseline up to Week 56
measure: Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2
timeFrame: From Baseline up to Week 21
measure: Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4
timeFrame: From Baseline up to Week 56
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Ps0026 103
city: Bruxelles
country: Belgium
facility: Ps0026 101
city: Bruxelles
country: Belgium
facility: Ps0026 107
city: Leuven
country: Belgium
facility: Ps0026 102
city: Maldegem
country: Belgium
facility: Ps0026 110
city: Mons
country: Belgium
facility: Ps0026 109
city: Namur
country: Belgium
facility: Ps0026 104
city: London
country: Canada
facility: Ps0026 208
city: London
country: Canada
facility: Ps0026 209
city: Markham
country: Canada
facility: Ps0026 201
city: Newmarket
country: Canada
facility: Ps0026 210
city: St- John's
country: Canada
facility: Ps0026 203
city: Toronto
country: Canada
facility: Ps0026 212
city: Waterloo
country: Canada
facility: Ps0026 205
city: Winnipeg
country: Canada
facility: Ps0026 204
city: Praha 1
country: Czechia
facility: Ps0026 303
city: Praha 5
country: Czechia
facility: Ps0026 301
city: Uherske Hradiste
country: Czechia
facility: Ps0026 302
city: Amiens Cedex
country: France
facility: Ps0026 408
city: Lorient
country: France
facility: Ps0026 404
city: Poitiers
country: France
facility: Ps0026 409
city: Rennes
country: France
facility: Ps0026 403
city: Toulon
country: France
facility: Ps0026 407
city: Bielefeld
country: Germany
facility: Ps0026 512
city: Bogen
country: Germany
facility: Ps0026 532
city: Dresden
country: Germany
facility: Ps0026 525
city: Düren
country: Germany
facility: Ps0026 506
city: Freiburg
country: Germany
facility: Ps0026 521
city: Gladbeck
country: Germany
facility: Ps0026 529
city: Hamburg
country: Germany
facility: Ps0026 523
city: Karlsruhe
country: Germany
facility: Ps0026 518
city: Leipzig
country: Germany
facility: Ps0026 519
city: Magdeburg
country: Germany
facility: Ps0026 537
city: Memmingen
country: Germany
facility: Ps0026 530
city: Merzig
country: Germany
facility: Ps0026 516
city: München
country: Germany
facility: Ps0026 517
city: München
country: Germany
facility: Ps0026 527
city: Nürnberg
country: Germany
facility: Ps0026 515
city: Potsdam
country: Germany
facility: Ps0026 501
city: Quedlinburg
country: Germany
facility: Ps0026 511
city: Remscheid
country: Germany
facility: Ps0026 505
city: Athens
country: Greece
facility: Ps0026 603
city: Athens
country: Greece
facility: Ps0026 609
city: Athens
country: Greece
facility: Ps0026 610
city: Chaidari
country: Greece
facility: Ps0026 601
city: Larissa
country: Greece
facility: Ps0026 606
city: Patras
country: Greece
facility: Ps0026 608
city: Pireas
country: Greece
facility: Ps0026 607
city: Thessaloniki
country: Greece
facility: Ps0026 604
city: Thessaloniki
country: Greece
facility: Ps0026 605
city: Bari
country: Italy
facility: Ps0026 707
city: Bologna
country: Italy
facility: Ps0026 714
city: Brescia
country: Italy
facility: Ps0026 711
city: Catania
country: Italy
facility: Ps0026 712
city: Firenze
country: Italy
facility: Ps0026 710
city: Genova
country: Italy
facility: Ps0026 702
city: L'aquila
country: Italy
facility: Ps0026 706
city: Napoli
country: Italy
facility: Ps0026 701
city: Roma
country: Italy
facility: Ps0026 709
city: Roma
country: Italy
facility: Ps0026 713
city: San Donato Milanese
country: Italy
facility: Ps0026 704
city: Torino
country: Italy
facility: Ps0026 715
city: Torrette DI Ancona
country: Italy
facility: Ps0026 708
city: Badalona
country: Spain
facility: Ps0026 807
city: Barcelona
country: Spain
facility: Ps0026 809
city: Barcelona
country: Spain
facility: Ps0026 812
city: Pontevedra
country: Spain
facility: Ps0026 804
city: Sant Joan Despí
country: Spain
facility: Ps0026 806
city: Vigo
country: Spain
facility: Ps0026 818
city: Bradford
country: United Kingdom
facility: Ps0026 902
city: Dunfermline
country: United Kingdom
facility: Ps0026 909
city: Glasgow
country: United Kingdom
facility: Ps0026 914
city: Hertfordshire
country: United Kingdom
facility: Ps0026 916
city: Kingston Upon Thames
country: United Kingdom
facility: Ps0026 911
city: Leeds
country: United Kingdom
facility: Ps0026 905
city: Newcastle Upon Tyne
country: United Kingdom
facility: Ps0026 904
city: Salford
country: United Kingdom
facility: Ps0026 901
city: Wakefield
country: United Kingdom
facility: Ps0026 915
city: York
country: United Kingdom
facility: Ps0026 908
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: