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

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Certolizumab pegol

• 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

Study Timeline

• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-08-21
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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

• 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 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, Belgium

Ps0026 208; 🇨🇦 London, Canada

Ps0026 209; 🇨🇦 London, Canada

Ps0026 201; 🇨🇦 Markham, Canada

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