A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice
- Registration Number
- NCT04053881
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
- 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
Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Certolizumab pegol Certolizumab pegol Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
- Primary Outcome Measures
Name Time Method Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2 From Baseline up to Week 21 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).
- Secondary Outcome Measures
Name Time Method Change from Baseline in Dermatology Life Quality Index score at observational point 2 From Baseline up to Week 21 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).
Change from Baseline in Dermatology Life Quality Index score at observational point 4 From Baseline up to Week 56 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).
Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4 From Baseline up to Week 56 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).
Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2 From Baseline up to Week 21 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).
Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4 From Baseline up to Week 56 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).
Trial Locations
- Locations (79)
Ps0026 529
🇩🇪Gladbeck, Germany
Ps0026 518
🇩🇪Karlsruhe, Germany
Ps0026 532
🇩🇪Bogen, Germany
Ps0026 902
🇬🇧Bradford, United Kingdom
Ps0026 914
🇬🇧Glasgow, United Kingdom
Ps0026 911
🇬🇧Kingston Upon Thames, United Kingdom
Ps0026 506
🇩🇪Düren, Germany
Ps0026 102
🇧🇪Leuven, Belgium
Ps0026 104
🇧🇪Namur, Belgium
Ps0026 209
🇨🇦London, Canada
Ps0026 107
🇧🇪Bruxelles, Belgium
Ps0026 110
🇧🇪Maldegem, Belgium
Ps0026 103
🇧🇪Brussels, Belgium
Ps0026 409
🇫🇷Poitiers, France
Ps0026 407
🇫🇷Toulon, France
Ps0026 512
🇩🇪Bielefeld, Germany
Ps0026 525
🇩🇪Dresden, Germany
Ps0026 203
🇨🇦St- John's, Canada
Ps0026 204
🇨🇦Winnipeg, Canada
Ps0026 403
🇫🇷Rennes, France
Ps0026 302
🇨🇿Uherske Hradiste, Czechia
Ps0026 516
🇩🇪Merzig, Germany
Ps0026 527
🇩🇪München, Germany
Ps0026 515
🇩🇪Nürnberg, Germany
Ps0026 807
🇪🇸Badalona, Spain
Ps0026 714
🇮🇹Bologna, Italy
Ps0026 603
🇬🇷Athens, Greece
Ps0026 608
🇬🇷Patras, Greece
Ps0026 604
🇬🇷Thessaloniki, Greece
Ps0026 501
🇩🇪Potsdam, Germany
Ps0026 610
🇬🇷Athens, Greece
Ps0026 511
🇩🇪Quedlinburg, Germany
Ps0026 505
🇩🇪Remscheid, Germany
Ps0026 609
🇬🇷Athens, Greece
Ps0026 711
🇮🇹Brescia, Italy
Ps0026 706
🇮🇹L'aquila, Italy
Ps0026 809
🇪🇸Barcelona, Spain
Ps0026 804
🇪🇸Pontevedra, Spain
Ps0026 701
🇮🇹Napoli, Italy
Ps0026 916
🇬🇧Hertfordshire, United Kingdom
Ps0026 915
🇬🇧Wakefield, United Kingdom
Ps0026 212
🇨🇦Toronto, Canada
Ps0026 205
🇨🇦Waterloo, Canada
Ps0026 519
🇩🇪Leipzig, Germany
Ps0026 517
🇩🇪München, Germany
Ps0026 109
🇧🇪Mons, Belgium
Ps0026 201
🇨🇦Markham, Canada
Ps0026 208
🇨🇦London, Canada
Ps0026 210
🇨🇦Newmarket, Canada
Ps0026 301
🇨🇿Praha 5, Czechia
Ps0026 303
🇨🇿Praha 1, Czechia
Ps0026 408
🇫🇷Amiens Cedex, France
Ps0026 404
🇫🇷Lorient, France
Ps0026 521
🇩🇪Freiburg, Germany
Ps0026 523
🇩🇪Hamburg, Germany
Ps0026 530
🇩🇪Memmingen, Germany
Ps0026 537
🇩🇪Magdeburg, Germany
Ps0026 601
🇬🇷Chaidari, Greece
Ps0026 606
🇬🇷Larissa, Greece
Ps0026 607
🇬🇷Pireas, Greece
Ps0026 605
🇬🇷Thessaloniki, Greece
Ps0026 707
🇮🇹Bari, Italy
Ps0026 702
🇮🇹Genova, Italy
Ps0026 709
🇮🇹Roma, Italy
Ps0026 710
🇮🇹Firenze, Italy
Ps0026 712
🇮🇹Catania, Italy
Ps0026 713
🇮🇹Roma, Italy
Ps0026 704
🇮🇹San Donato Milanese, Italy
Ps0026 715
🇮🇹Torino, Italy
Ps0026 708
🇮🇹Torrette DI Ancona, Italy
Ps0026 812
🇪🇸Barcelona, Spain
Ps0026 818
🇪🇸Vigo, Spain
Ps0026 806
🇪🇸Sant Joan Despí, Spain
Ps0026 909
🇬🇧Dunfermline, United Kingdom
Ps0026 905
🇬🇧Leeds, United Kingdom
Ps0026 904
🇬🇧Newcastle Upon Tyne, United Kingdom
Ps0026 908
🇬🇧York, United Kingdom
Ps0026 901
🇬🇧Salford, United Kingdom
Ps0026 101
🇧🇪Bruxelles, Belgium