A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice
CIMREAL
A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice
1 other identifier
observational
412
9 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2022
CompletedJanuary 23, 2023
January 1, 2023
3.3 years
August 9, 2019
January 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change from Baseline in Dermatology Life Quality Index score at observational point 2
From Baseline up to Week 21
Change from Baseline in Dermatology Life Quality Index score at observational point 4
From Baseline up to Week 56
Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4
From Baseline up to Week 56
Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2
From Baseline up to Week 21
Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4
From Baseline up to Week 56
Study Arms (1)
Certolizumab pegol
Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
Interventions
Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection
Eligibility Criteria
Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
You may qualify if:
- 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
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Ps0026 101
Brussels, Belgium
Ps0026 103
Brussels, Belgium
Ps0026 107
Brussels, Belgium
Ps0026 102
Leuven, Belgium
Ps0026 110
Maldegem, Belgium
Ps0026 109
Mons, Belgium
Ps0026 104
Namur, Belgium
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, Canada
Ps0026 301
Prague, Czechia
Ps0026 303
Prague, Czechia
Ps0026 302
Uherské Hradiště, Czechia
Ps0026 408
Amiens, France
Ps0026 404
Lorient, France
Ps0026 409
Poitiers, France
Ps0026 403
Rennes, France
Ps0026 407
Toulon, France
Ps0026 512
Bielefeld, Germany
Ps0026 532
Bogen, Germany
Ps0026 525
Dresden, Germany
Ps0026 506
Düren, Germany
Ps0026 521
Freiburg im Breisgau, 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
Nuremberg, Germany
Ps0026 501
Potsdam, Germany
Ps0026 511
Quedlinburg, Germany
Ps0026 505
Remscheid, Germany
Ps0026 603
Athens, Greece
Ps0026 609
Athens, Greece
Ps0026 610
Athens, Greece
Ps0026 601
Chaïdári, Greece
Ps0026 606
Larissa, Greece
Ps0026 608
Pátrai, Greece
Ps0026 607
Piraeus, Greece
Ps0026 604
Thessaloniki, Greece
Ps0026 605
Thessaloniki, Greece
Ps0026 707
Bari, Italy
Ps0026 714
Bologna, Italy
Ps0026 711
Brescia, Italy
Ps0026 712
Catania, Italy
Ps0026 710
Florence, 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, Italy
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, Spain
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, United Kingdom
Related Publications (1)
Korge B, Vanhooteghem O, Lynde CW, Machovcova A, Perrussel M, Lazaridou E, Marasca C, Sarro DV, Pousa ID, Fierens F, Williams P, Shimizu S, Heidbrede T, Warren RB. Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study. Dermatol Ther (Heidelb). 2024 Aug;14(8):2077-2092. doi: 10.1007/s13555-024-01210-3. Epub 2024 Jun 27.
PMID: 38937404DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 13, 2019
Study Start
August 21, 2019
Primary Completion
December 2, 2022
Study Completion
December 2, 2022
Last Updated
January 23, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.