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Plaque PsoriasisCIMREALNCT04053881

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

An observational study of Plaque Psoriasis, run by UCB Biopharma SRL at 79 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Certolizumab pegol
Type of treatment
Injection or infusion
How many people
412 participants
Where
79 sitesin 9 countries
Study dates
21 Aug 2019to 2 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Not applicable

Trial locations and contacts

79 sites in 9 countries.

79 sites in 9 countries

Germany18 sites

  • Ps0026 512

    Bielefeld

  • Ps0026 532

    Bogen

  • Ps0026 525

    Dresden

  • Ps0026 506

    Düren

  • Ps0026 521

    Freiburg im Breisgau

  • Ps0026 529

    Gladbeck

  • Ps0026 523

    Hamburg

  • Ps0026 518

    Karlsruhe

  • Ps0026 519

    Leipzig

  • Ps0026 537

    Magdeburg

  • Ps0026 530

    Memmingen

  • Ps0026 516

    Merzig

  • Ps0026 517

    München

  • Ps0026 527

    München

  • Ps0026 515

    Nuremberg

  • Ps0026 501

    Potsdam

  • Ps0026 511

    Quedlinburg

  • Ps0026 505

    Remscheid

Other trials in Germany

Italy13 sites

  • Ps0026 707

    Bari

  • Ps0026 714

    Bologna

  • Ps0026 711

    Brescia

  • Ps0026 712

    Catania

  • Ps0026 710

    Florence

  • Ps0026 702

    Genova

  • Ps0026 706

    L’Aquila

  • Ps0026 701

    Naples

  • Ps0026 709

    Roma

  • Ps0026 713

    Roma

  • Ps0026 704

    San Donato Milanese

  • Ps0026 715

    Torino

  • Ps0026 708

    Torrette DI Ancona

Other trials in Italy

United Kingdom10 sites

  • Ps0026 902

    Bradford

  • Ps0026 909

    Dunfermline

  • Ps0026 914

    Glasgow

  • Ps0026 916

    Hertfordshire

  • Ps0026 911

    Kingston upon Thames

  • Ps0026 905

    Leeds

  • Ps0026 904

    Newcastle upon Tyne

  • Ps0026 901

    Salford

  • Ps0026 915

    Wakefield

  • Ps0026 908

    York

Other trials in United Kingdom

Greece9 sites

  • Ps0026 603

    Athens

  • Ps0026 609

    Athens

  • Ps0026 610

    Athens

  • Ps0026 601

    Chaïdári

  • Ps0026 606

    Larissa

  • Ps0026 608

    Pátrai

  • Ps0026 607

    Piraeus

  • Ps0026 604

    Thessaloniki

  • Ps0026 605

    Thessaloniki

Other trials in Greece

Canada8 sites

  • Ps0026 208

    London

  • Ps0026 209

    London

  • Ps0026 201

    Markham

  • Ps0026 210

    Newmarket

  • Ps0026 203

    St. John's

  • Ps0026 212

    Toronto

  • Ps0026 205

    Waterloo

  • Ps0026 204

    Winnipeg

Other trials in Canada

Belgium7 sites

  • Ps0026 101

    Brussels

  • Ps0026 103

    Brussels

  • Ps0026 107

    Brussels

  • Ps0026 102

    Leuven

  • Ps0026 110

    Maldegem

  • Ps0026 109

    Mons

  • Ps0026 104

    Namur

Other trials in Belgium

Spain6 sites

  • Ps0026 807

    Badalona

  • Ps0026 809

    Barcelona

  • Ps0026 812

    Barcelona

  • Ps0026 804

    Pontevedra

  • Ps0026 806

    Sant Joan Despí

  • Ps0026 818

    Vigo

Other trials in Spain

France5 sites

  • Ps0026 408

    Amiens

  • Ps0026 404

    Lorient

  • Ps0026 409

    Poitiers

  • Ps0026 403

    Rennes

  • Ps0026 407

    Toulon

Other trials in France

Czechia3 sites

  • Ps0026 301

    Prague

  • Ps0026 303

    Prague

  • Ps0026 302

    Uherské Hradiště

Other trials in Czechia

About this study

Official title: 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.

Being tested
Certolizumab pegol
Keywords
Plaque psoriasis, Cimzia, Certolizumab pegol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Certolizumab pegolDrug

    Also called Cimzia, CDP870

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

Study groups in NCT04053881
Study groupRoleWhat they receive
Certolizumab pegolPlaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
Receives: Drug: Certolizumab pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From Baseline up to Week 21

Secondary outcomes (5)

  1. 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).

    Measured: From Baseline up to Week 21

  2. 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).

    Measured: From Baseline up to Week 56

  3. 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).

    Measured: From Baseline up to Week 56

  4. 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).

    Measured: From Baseline up to Week 21

  5. 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).

    Measured: From Baseline up to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2019
  2. Study start21 Aug 2019
  3. Primary completion2 Dec 2022
  4. Study completion2 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053881
Sponsor's protocol ID
PS0026
Acronym
CIMREAL
Status last verified
Jan 2023
First submitted
9 Aug 2019
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data from non-interventional studies is outside of UCB's data sharing policy and is unavailable for sharing.

Publications

  • Korge B, Vanhooteghem O, Lynde CW, Machovcova A, Perrussel M, Lazaridou E, Marasca C, Sarro DV, Pousa ID, Fierens F, Williams P, Shimizu S, Heidbrede T, Warren RB. Certolizumab Pegol for the Treatment of Plaque Psoriasis in Routine Clinical Practice: One-Year Results from the CIMREAL Study. Dermatol Ther (Heidelb). 2024 Aug;14(8):2077-2092. doi: 10.1007/s13555-024-01210-3. Epub 2024 Jun 27.

    PubMed 38937404

Questions about this trial

What is this clinical trial studying?

An observational study of Plaque Psoriasis, run by UCB Biopharma SRL at 79 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany, Italy, United Kingdom, Greece, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving Psoriasis Area Severity Index 75% response at observational point 2 (time frame: From Baseline up to Week 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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