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

November 26, 2023 updated by: Hira Tariq, Services Institute of Medical Sciences, Pakistan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients of Hidradenitis suppurativa resistant to conventional therapy
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
Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab-dyyb that inhibits the activity of tumour necrosis factor (TNF)-alpha.
Other Names:
  • Remsima (infliximab-dyyb biosimilar)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 15, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2022/101/SIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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