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Trial record 4 of 1713 for:    psoriasis

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

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ClinicalTrials.gov Identifier: NCT04053881
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Brief Summary:
The purpose of the study is to to assess the effectiveness of certolizumab pegol in patients with moderate to severe plaque psoriasis as part of routine clinical practice.

Condition or disease Intervention/treatment
Plaque Psoriasis Drug: Certolizumab pegol

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Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Plaque psoriasis patients who have been newly prescribed certolizumab pegol (CZP).
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053881


Contacts
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Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

Locations
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Canada
Ps0026 201 Recruiting
Markham, Canada
Czechia
Ps0026 303 Recruiting
Praha, Czechia
Ps0026 302 Recruiting
Uherské Hradiště, Czechia
Germany
Ps0026 506 Recruiting
Düren, Germany
Ps0026 501 Recruiting
Potsdam, Germany
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT04053881     History of Changes
Other Study ID Numbers: PS0026
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Plaque psoriasis
Cimzia
Certolizumab pegol
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents