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

Services Institute of Medical Sciences, Pakistan

Status and phase: Completed; Early Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Biological: Infliximab-dyyb biosimilar

Study type: Interventional

Funder types: Other

Identifiers

NCT05663268

IRB/2022/101/SIMS

Details and patient eligibility

About

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

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Patients of Hidradenitis suppurativa resistant to conventional therapy

Experimental group

Description:

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.

Treatment:

Biological: Infliximab-dyyb biosimilar