search
Back to results

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

Primary Purpose

Hidradenitis Suppurativa

Status
Active
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Infliximab biosimilar
Sponsored by
Services Institute of Medical Sciences, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, Infliximab biosimilar, Remsima, Efficacy, safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Services Institute of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients of Hidradenitis suppurativa resistant to conventional therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Hidradenitis Suppurativa Clinical Response (HiSCR)
50% reduction in score
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
50% reduction
Dermatology Life Quality Index (DLQI)
50% reduction

Secondary Outcome Measures

Full Information

First Posted
December 15, 2022
Last Updated
December 22, 2022
Sponsor
Services Institute of Medical Sciences, Pakistan
search

1. Study Identification

Unique Protocol Identification Number
NCT05663268
Brief Title
Efficacy and Safety of Infliximab Biosimilar in Treatment of Resistant Hidradenitis Suppurativa
Official Title
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Institute of Medical Sciences, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis suppurativa, Infliximab biosimilar, Remsima, Efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients of Hidradenitis suppurativa resistant to conventional therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Infliximab biosimilar
Other Intervention Name(s)
Remsima
Intervention Description
Remsima for subcutaneous injection is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)-alpha.
Primary Outcome Measure Information:
Title
Hidradenitis Suppurativa Clinical Response (HiSCR)
Description
50% reduction in score
Time Frame
14 weeks
Title
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
Description
50% reduction
Time Frame
14 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
50% reduction
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hira Tariq, FCPS Derma
Organizational Affiliation
Services Institute of Medical Sciences, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Institute of Medical Sciences
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17587838
Citation
Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.
Results Reference
result
PubMed Identifier
14632813
Citation
Sullivan TP, Welsh E, Kerdel FA, Burdick AE, Kirsner RS. Infliximab for hidradenitis suppurativa. Br J Dermatol. 2003 Nov;149(5):1046-9. doi: 10.1111/j.1365-2133.2003.05663.x.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs