Observational Study of Tildrakizumab in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

NCT ID: NCT04203693

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

331 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-30

Study Completion Date

2024-04-30

Brief Summary

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The observational, non-interventional study will assess the efficacy, safety, prescription and utilization patterns of Tildrakizumab in participants with moderate to severe plaque psoriasis in routine clinical practice.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: Tildrakizumab Treated Participants

Participants will be treated with tildrakizumab who have participated in prior tildrakizumab studies

Tildrakizumab

Intervention Type DRUG

The study physicians will choose the treatment independently of the enrolment in the study according to routine care.

Cohort 2: Newly Tildrakizumab Prescribed Participants

Participants will be newly prescribed tildrakizumab (a prescription has occurred independently of the enrolment in the study)

Tildrakizumab

Intervention Type DRUG

The study physicians will choose the treatment independently of the enrolment in the study according to routine care.

Interventions

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Tildrakizumab

The study physicians will choose the treatment independently of the enrolment in the study according to routine care.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent form.
* Age \>= 18years.
* Moderate to severe chronic plaque psoriasis diagnosis.
* Participants who have participated in Tildrakizumab (Ilumetri®) clinical trials (Cohort 1) OR participants who, according to the physician's therapeutic decision, should start the treatment with Tildrakizumab (Ilumetri®) (Cohort 2).

Exclusion Criteria

* Unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almirall, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

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Investigator Site 1

Vienna, , Austria

Site Status

Investigational site 5

Augsburg, , Germany

Site Status

Investigational site 10

Berlin, , Germany

Site Status

Investigational site 11

Berlin, , Germany

Site Status

Investigational site 13

Berlin, , Germany

Site Status

Investigational site 8

Erlangen, , Germany

Site Status

Investigational site 9

Greifswald, , Germany

Site Status

Investigational site 1

Hamburg, , Germany

Site Status

Investigational site 2

Hamburg, , Germany

Site Status

Investigational site 7

Kiel, , Germany

Site Status

Investigational site 3

Lübeck, , Germany

Site Status

Investigational site 6

München, , Germany

Site Status

Investigational site 12

Oberursel, , Germany

Site Status

Investigational site 4

Quedlinburg, , Germany

Site Status

Investigational site 6

Catania, , Italy

Site Status

Investigational site 7

Genova, , Italy

Site Status

Investigational site 3

Modena, , Italy

Site Status

Investigational site 4

Parma, , Italy

Site Status

Investigational site 1

Roma, , Italy

Site Status

Investigational site 2

Roma, , Italy

Site Status

Investigational site 5

Roma, , Italy

Site Status

Investigational site 1

Breda, , Netherlands

Site Status

Countries

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Austria Germany Italy Netherlands

Other Identifiers

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NIS Study M-14745-43

Identifier Type: -

Identifier Source: org_study_id

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