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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Noninterventional, Prospective Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Moderate to Severe Plaque Psoriasis in Daily Practice

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Certolizumab pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Certolizumab pegol<br>Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP). | Drug: Certolizumab pegol<br>* Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection<br>* Other names: CDP870;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque psoriasis, Cimzia, Certolizumab pegol