A Study of Moderate-to-severe Plaque Psoriasis Patients Response to Secukinumab Treatment in Real-world Setting

NCT ID: NCT05787236

Last Updated: 2023-03-28

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

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2022-03-15

Brief Summary

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This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).

Detailed Description

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Conditions

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Moderate-to-severe Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Secukinumab

Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged at least 18 years old.
* Diagnosed as moderate-to-severe plaque type psoriasis with PASI score ≥ 5 prior to initiating secukinumab treatment.
* Treated with secukinumab for a minimum of 8 weeks after the initial secukinumab treatment without any interruption.
* Patients included in this study received the initial secukinumab treatment within the period of 1 August 2017 to 31 October 2019. With the secondary endpoint of 52 weeks, the latest recorded data included in the analysis was recorded on 31 October 2020.

Exclusion Criteria

* Patients with other types of psoriasis.
* Patients with incomplete information on PASI score at Weeks 0, 8, and 16 in their medical records.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Mangga Besar Clinic

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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CAIN457AID01

Identifier Type: -

Identifier Source: org_study_id

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