Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia

NCT06785779 | Recruiting

• 1 other identifier: CAIN457MSA01
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

Hidradenitis Suppurativa; HS; secukinumab; NIS; Saudi Arabia

Outcome Measures

Primary Outcomes (1)

• Mean Score in the Treatment Satisfaction Questionnaire (TSQM)

  TSQM questionnaire consists of 14 questions with a score ranging from 0 to 100. The questionnaire has four subscales, effectiveness (3 questions), side Effects (5 questions), convenience (3 questions) and global Satisfaction (3 questions). TSQM scoring is calculated by each subscale, which ranges from 0 to 100, with higher scores indicating higher patient satisfaction with medication.

  Week 24

Secondary Outcomes (15)

• Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire

  Baseline, week 24

• Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11)

  Baseline, week 24

• Baseline characteristics-age

  Baseline

• Baseline characteristics - Ethnicity

  Baseline

• Baseline characteristics - Socio-economic status

  Baseline

Study Arms (1)

Secukinumab

Patients who are newly initiated on Secukinumab

Other: Secukinmab

Interventions

Secukinmab OTHER

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

Also known as: Cosentyx

Secukinumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are newly initiated on Secukinumab as per locally approved labels and routine clinical practice will be enrolled over a period of 6 months and followed up for 24 weeks to assess study outcomes

You may qualify if:

• Male or Female adult patients ≥18 years of age at the time of data collection.
• Patient with a confirmed diagnosis of active moderate to severe HS.
• Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
• Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
• Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.

You may not qualify if:

• Patient's refusal to be included in the study or refusal to sign the ICF.
• A history of off-label indication uses of biological treatment or JAK inhibitor.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Riyadh, SAU, 11525, Saudi Arabia

RECRUITING

Novartis Investigative Site

Jeddah, 21391, Saudi Arabia

RECRUITING

Novartis Investigative Site

Jeddah, 23311, Saudi Arabia

RECRUITING

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 21, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (4)