A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice

Plaque Psoriasis Clinical Trial

— CIMREAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053881
• Other study ID #: PS0026
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

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