Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.

NCT06785675 | Active Not Recruiting

• 1 other identifier: CAIN457AAE02
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire

  TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction. 4 Domains: Effectiveness Side Effects Convenience Global Satisfaction

  At Week 24

Secondary Outcomes (17)

• Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire

  Baseline, Week 24

• Change from baseline in the Numerical Rating Scale (NRS)

  Baseline, Week 24

• Age (years)

  Baseline

• Gender (male/female)

  Baseline

• Ethnicity

  Baseline

Study Arms (1)

Secukinumab

Patients who are newly initiated on treatment with Secukinumab

Other: Secukinumab

Interventions

Secukinumab OTHER

This is an observational study. There is no treatment allocation.

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 with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.

You may qualify if:

• Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
• Male or Female adult patients ≥ 18 years of age at the time of data collection
• Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
• Agreed to sign an informed consent to be able to fill in the questionnaires.

You may not qualify if:

• Patient's refusal to be included in the study or refusal to sign the informed consent.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates

Location

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Location

Novartis Investigative Site

Ras al-Khaimah, United Arab Emirates

Location

Novartis Investigative Site

Sharjah city, United Arab Emirates

Location

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

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 21, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

AE (4)