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

January 20, 2023 updated by: UCB Biopharma SRL

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Ps0026 103
      • Bruxelles, Belgium
        • Ps0026 101
      • Bruxelles, Belgium
        • Ps0026 107
      • Leuven, Belgium
        • Ps0026 102
      • Maldegem, Belgium
        • Ps0026 110
      • Mons, Belgium
        • Ps0026 109
      • Namur, Belgium
        • Ps0026 104
  • Canada
      • London, Canada
        • Ps0026 208
      • London, Canada
        • Ps0026 209
      • Markham, Canada
        • Ps0026 201
      • Newmarket, Canada
        • Ps0026 210
      • St- John's, Canada
        • Ps0026 203
      • Toronto, Canada
        • Ps0026 212
      • Waterloo, Canada
        • Ps0026 205
      • Winnipeg, Canada
        • Ps0026 204
  • Czechia
      • Praha 1, Czechia
        • Ps0026 303
      • Praha 5, Czechia
        • Ps0026 301
      • Uherske Hradiste, Czechia
        • Ps0026 302
  • France
      • Amiens Cedex, France
        • Ps0026 408
      • Lorient, France
        • Ps0026 404
      • Poitiers, France
        • Ps0026 409
      • Rennes, France
        • Ps0026 403
      • Toulon, France
        • Ps0026 407
  • Germany
      • Bielefeld, Germany
        • Ps0026 512
      • Bogen, Germany
        • Ps0026 532
      • Dresden, Germany
        • Ps0026 525
      • Düren, Germany
        • Ps0026 506
      • Freiburg, Germany
        • Ps0026 521
      • Gladbeck, Germany
        • Ps0026 529
      • Hamburg, Germany
        • Ps0026 523
      • Karlsruhe, Germany
        • Ps0026 518
      • Leipzig, Germany
        • Ps0026 519
      • Magdeburg, Germany
        • Ps0026 537
      • Memmingen, Germany
        • Ps0026 530
      • Merzig, Germany
        • Ps0026 516
      • München, Germany
        • Ps0026 517
      • München, Germany
        • Ps0026 527
      • Nürnberg, Germany
        • Ps0026 515
      • Potsdam, Germany
        • Ps0026 501
      • Quedlinburg, Germany
        • Ps0026 511
      • Remscheid, Germany
        • Ps0026 505
  • Greece
      • Athens, Greece
        • Ps0026 603
      • Athens, Greece
        • Ps0026 609
      • Athens, Greece
        • Ps0026 610
      • Chaidari, Greece
        • Ps0026 601
      • Larissa, Greece
        • Ps0026 606
      • Patras, Greece
        • Ps0026 608
      • Pireas, Greece
        • Ps0026 607
      • Thessaloniki, Greece
        • Ps0026 604
      • Thessaloniki, Greece
        • Ps0026 605
  • Italy
      • Bari, Italy
        • Ps0026 707
      • Bologna, Italy
        • Ps0026 714
      • Brescia, Italy
        • Ps0026 711
      • Catania, Italy
        • Ps0026 712
      • Firenze, Italy
        • Ps0026 710
      • Genova, Italy
        • Ps0026 702
      • L'aquila, Italy
        • Ps0026 706
      • Napoli, Italy
        • Ps0026 701
      • Roma, Italy
        • Ps0026 709
      • Roma, Italy
        • Ps0026 713
      • San Donato Milanese, Italy
        • Ps0026 704
      • Torino, Italy
        • Ps0026 715
      • Torrette DI Ancona, Italy
        • Ps0026 708
  • Spain
      • Badalona, Spain
        • Ps0026 807
      • Barcelona, Spain
        • Ps0026 809
      • Barcelona, Spain
        • Ps0026 812
      • Pontevedra, Spain
        • Ps0026 804
      • Sant Joan Despí, Spain
        • Ps0026 806
      • Vigo, Spain
        • Ps0026 818
  • United Kingdom
      • Bradford, United Kingdom
        • Ps0026 902
      • Dunfermline, United Kingdom
        • Ps0026 909
      • Glasgow, United Kingdom
        • Ps0026 914
      • Hertfordshire, United Kingdom
        • Ps0026 916
      • Kingston Upon Thames, United Kingdom
        • Ps0026 911
      • Leeds, United Kingdom
        • Ps0026 905
      • Newcastle Upon Tyne, United Kingdom
        • Ps0026 904
      • Salford, United Kingdom
        • Ps0026 901
      • Wakefield, United Kingdom
        • Ps0026 915
      • York, United Kingdom
        • Ps0026 908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Certolizumab pegol
Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
Drug: Certolizumab pegol
Active Substance: Certolizumab Pegol Pharmaceutical Form: Prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From Baseline up to Week 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
From Baseline up to Week 21
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).
From Baseline up to Week 56
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).
From Baseline up to Week 56
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).
From Baseline up to Week 21
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).
From Baseline up to Week 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma SRL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS0026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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