Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa

Study Overview
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Brief Summary
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The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are: how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy

Detailed Description
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The aim of this clinical trial is to assess the efficacy and safety of Infliximab-dyyb biosimilar in patients of resistant Hidradenitis suppurativa. The main question it aims to answer are: how effective is infliximab biosimilar in treating resistant Hidradentis suppurativa Is infliximab biosimilar safe in these patients Patients will receive weekly injections of Infliximab Biosimilar Remsima, according to weight, for first 4 weeks, and then fortnightly for next 24 weeks. Patients will be followed up at 4, 14 and 24 weeks for assessment of safety and efficacy. Pre and post treatment HiSCR, IHS4, DLQI scores and photos will be taken for comparison at week 0, 4, 14 and 24. Details will be entered on predesigned proforma DATA ANALYSIS PROCEDURE: Data will be entered and analyzed using SPSS 20. Data will be stratified for role of effect modifiers.

Official Title
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Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Biological: Infliximab-dyyb biosimilar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of Hidradenitis suppurativa resistant to conventional therapy Exclusion Criteria: Immunocompromised patients Patients with connective tissue disorders patients having chronic infections like heapatitis, HIV or Tuberculosis Pregnant or lactating mothers hypersensitivity to biologics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients of Hidradenitis suppurativa resistant to conventional therapy<br>injection Infliximab-dyyb biosimilar (according to weight, single injection of 120mg if weight <80kg, 2 injections if weight > 80kg) will be injected subcutaneously at week 0,1, 2,3,4, and then fortnightly till 24 weeks. | Biological: Infliximab-dyyb biosimilar<br>* Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.<br>* Other names: Remsima (infliximab-dyyb biosimilar);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hidradenitis Suppurativa Clinical Response (HiSCR) | 50% reduction in score | 24 weeks | 
| Dermatology Life Quality Index (DLQI) | 50% reduction | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hidradenitis suppurativa, Infliximab biosimilar, Efficacy, safety