Plaque Psoriasis
Conditions
Keywords
Plaque psoriasis, Cimzia, Certolizumab pegol
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.
Interventions
DRUGCertolizumab pegol
Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection
Sponsors
UCB Biopharma SRL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium, Canada, Czechia, France, Germany, Greece, Italy, Spain, United Kingdom
Outcome results
None listed