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

NCT05787236 | Completed

• 1 other identifier: CAIN457AID01
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Moderate-to-severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16

  The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.

  Week 16

Secondary Outcomes (8)

• Percentage of patients achieving PASI 75 or higher response at Week 8

  Week 8

• Percentage of patients achieving PASI 90 or higher response at Week 16

  Week 16

• Percentage of patients achieving PASI 90 or higher response at Week 52

  Week 52

• Number of injections needed to achieve at least PASI 90

  Weeks 16 and 52

• Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab

  Week 16

Study Arms (1)

Secukinumab

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Mangga Besar Clinic

Jakarta, Indonesia

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: November 5, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

ID (1)