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Completed

NCT Number: NCT04053881

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ps0026 101, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol

Drug

Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection

Other names: Cimzia, CDP870

Primary outcomes

  1. Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2

    Time frame: 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 outcomes

  1. Change from Baseline in Dermatology Life Quality Index score at observational point 2

    Time frame: 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).

  2. Change from Baseline in Dermatology Life Quality Index score at observational point 4

    Time frame: 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).

  3. Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 4

    Time frame: 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).

  4. Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 2

    Time frame: 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).

  5. Percentage of patients achieving Psoriasis Area Severity Index 90% response at observational point 4

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study title

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

Acronym: CIMREAL

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2019
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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