Efficacy Of Secukinumab Vs Adalimumab in the treatment Of Hidradenitis Suppurativa: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Clinical response to treatment by assessing modified sartorius score
Study Overview
Brief Summary
This study is a randomized open labelled parallel group single centre trial to compare the safety and efficacy of secukinumab 300 mg and adalimumab 120 mg every 4 weekly for 6 months in 40 patients of hidradenitis suppurativa not responding to conventional therapies for more than 12 months.The study will be conducted in a tertiary care military hospital .Our primary objective is to compare the efficacy of secukinumab and adalimumab by assessing the clinical response in the form of modified sartorius score at 4 weekly intervals. The secondary objective is to assess the clinical response via patient satisfaction level and hurley staging. All the enrolled patients will be assessed at baseline followed by 4,8,12,16,20 and 24 weeks. Data will be assessed using appropriate statistical test for each of the variables.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases Of Hidradenitis Suppurativa with poor response to conventional therapy for more than 12 months.
Exclusion Criteria
- •Pregnant ladies, autoimmune disorders, immunocompromised patients.
Outcomes
Primary Outcomes
Clinical response to treatment by assessing modified sartorius score
Time Frame: 4 weekly
Secondary Outcomes
- Clinical response to treatment by assessing hurley staging & patient satisfaction level(4 weekly)
Investigators
Debatraya Paul
Military Hospital Jaipur