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

Sponsor
Services Institute of Medical Sciences, Pakistan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05663268
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this clinical trial is to assess the efficacy and safety of Infliximab 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 10 weeks. Patients will be followed up for 10 weeks post treatment for assessment of safety and efficacy

Condition or Disease Intervention/Treatment Phase
  • Biological: Infliximab biosimilar
 Early Phase 1

Detailed Description

The aim of this clinical trial is to assess the efficacy and safety of Infliximab 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 10 weeks. Patients will be followed up for 10 weeks post treatment 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 27. Data will be stratified for role of effect modifiers.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapiesAdult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients of Hidradenitis suppurativa resistant to conventional therapy

10 doses of injection Infliximab 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 for next 10 weeks.

Biological: Infliximab biosimilar
Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)-alpha.
Other Names:
  • Remsima

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hidradenitis Suppurativa Clinical Response (HiSCR) [14 weeks]

      50% reduction in score

    2. Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) [14 weeks]

      50% reduction

    3. Dermatology Life Quality Index (DLQI) [14 weeks]

      50% reduction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Services Institute of Medical Sciences Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • Services Institute of Medical Sciences, Pakistan

    Investigators

    • Principal Investigator: Hira Tariq, FCPS Derma, Services Institute of Medical Sciences, Lahore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hira Tariq, Dr, Services Institute of Medical Sciences, Pakistan
    ClinicalTrials.gov Identifier:
    NCT05663268
    Other Study ID Numbers:
    • HIDRADENITISremsima
    First Posted:
    Dec 23, 2022
    Last Update Posted:
    Dec 23, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hira Tariq, Dr, Services Institute of Medical Sciences, Pakistan
    Hidradenitis suppurativa
    Infliximab biosimilar
    Remsima
    Efficacy
    safety
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis
    Infliximab

    Study Results

    No Results Posted as of Dec 23, 2022