Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation

Hidradenitis Suppurativa Clinical Trial

— SPECTRA  

Official title:

Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444087
• Other study ID #: CAIN457MFR01
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: March 30, 2027

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.

Description:

This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France. This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation. Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 177
• Est. completion date: March 30, 2027
• Est. primary completion date: March 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Male and female patients = 18 years old,

2. Patients who do not object to participation in the study,

3. Diagnosis of HS clinically confirmed,

4. Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,

5. The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.

Exclusion Criteria:

1. Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,

2. Patients participating in a clinical trial.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms	Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.	Baseline, month 12
Secondary	Proportion of patients achieving at least a 30% reduction of NRS	Proportion of patients achieving at least a 30% reduction of NRS for at least one of the evaluated symptoms (pain, oozing and bad smell) and the proportion of patients achieving at least a 30% reduction of NRS for each symptom evaluated separately (pain, oozing and bad smell)	Baseline, month 3, month 6, month 18 and month 24
Secondary	Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)	The DLQI consists of ten questions regarding patients' perception of the impact of their disease on different aspects of their health-related quality of life (symptoms and feelings, impact on daily activities, leisure, work, school, personal relationships, and problems with treatment) over the last seven days. The highest possible total score for the DLQI is 30 and higher scores indicate a more severe impact on quality of life.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline	The impact of Hidradenitis Suppurativa (HS) on daily life will be studied using seven additional questions on the symptoms experienced by the patient and the impact of HS on daily life over the past three months: physical and psychological fatigue, anxiety, sleep quality, discomfort with dressing, discomfort with washing, and sex and love life. Responses will be collected at each visit by a four-point Likert scale. The improvement will be defined by the decrease of at least one point on the Likert scale between the enrolment visit and the follow-up visits.	Baseline, up to 24 months
Secondary	Proportion of patients having stopped at tobacco, alcohol and cannabis use	The proportion of patients having stopped at least one of these substances during follow-up will be calculated, and as well as the proportion of patients having stopped one of these substances without using them again until the end of follow-up.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Absenteeism due to Hidradenitis Suppurativa	Absenteeism due to HS will be measured by the number of days off taken and the number of days on sick leave over the last three months (enrolment visit and visit at 3 months) or since the last visit (visits at 6, 12, 18 and 24 months). The number of days and its evolution since enrolment will be presented at each visit.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline	The family member's quality of life will be measured using the FDLQI. The FDLQI is a 10-item-questionnaire with a total score resulting in a maximum of 30 and a minimum of 0 (the higher the score, the more quality of life is impaired). The questionnaire will be proposed to one of the family members (one per patient, the same person throughout the study) going with the patient to the baseline visit and 3, 6, 12, 18 and 24 months after secukinumab initiation. The assessment will refer to the last seven days.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Secukinumab dose regimen prescribed at baseline	Secukinumab dose regimen prescribed at baseline to describe the use of secukinumab.	Baseline
Secondary	Proportion of patients receiving up-titration or down-titration	Proportion of patients receiving up-titration (q4w-to-q2w) or down-titration (q2w-to-q4w) and proportion of patients receiving more than one up-and/or down-titration	Month 3, month 6, month 12, month 18 and month 24
Secondary	Time spent under each treatment regimen	Time spent under each treatment regimen (q4w and q2w) and reason for change	Up to 24 months
Secondary	Total duration of secukinumab treatment	Total duration of secukinumab treatment (i.e. time elapsed until treatment is discontinued), reason for discontinuation	Up to 24 months
Secondary	Proportion of patients with at least one temporary discontinuation	Proportion of patients with at least one temporary discontinuation and its reason	Up to 24 months
Secondary	Proportion of patients taking all prescribed doses	Proportion of patients taking all prescribed doses to measure the treatment compliance	Up to 24 months
Secondary	Proportion of patients achieving a reduction in IHS4	Proportion of patients achieving at least 55%, 75% and 100% reduction in International Hidradenitis Suppurativa Severity Score System (IHS4) (IHS4-55, 75, 100).; The IHS4 score corresponds to: (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of drainage tunnels (fistulas/sinuses) multiplied by 4]. A score of 3 or less corresponds to mild HS, a score of 4 to 10 to moderate HS and a score of 11 or more to severe HS	Baseline, month 3, month 6, month 12, month 18 and month 24
Secondary	Evolution of AN count	Evolution of AN count (total abscesses and inflammatory nodules)	Baseline, month 3, month 6, month 12, month 18 and month 24
Secondary	Percentages of patients with onset or worsening of flares	Percentages of patients with onset or worsening of flares will be described from the data concerning flares collected by the physician at each visit.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)	Itching due to pruritus will be evaluated using an 11-point NRS scale with 0 being "no itch" and 10 being the worst itch imaginable.	Baseline, month 3, month 6, month 18 and month 24
Secondary	Proportion of patients receiving at least one medication for HS	Treatments of interest will include systemic antibiotics, pain medications and psychotropic drugs.	Month 3, month 6, month 18 and month 24
Secondary	Proportion of patients who had a surgical procedure	Proportion of patients who had a surgical procedure will be provided	Up to 24 months
Secondary	Proportion of patients with stable/increased/decreased dressing used since the baseline visit	Use of dressings and protections for wound care after secukinumab initiation, evaluated by the use of dressings and protections in the seven days prior to visits (data collected by the patient)	Baseline, month 3, month 6, month 18 and month 24
Secondary	Number of patients by reasons for secukinumab initiation	Description of the reasons for secukinumab initiation (e.g.: patient complaints, clinical symptoms, safety events) declared by the participating physician.	Baseline