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

NCT05663268 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-11-29

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Services Institute of Medical Sciences, Pakistan

    lead OTHER_GOV

Principal Investigators

  • Hira Tariq, FCPS Derma · Services Institute of Medical Sciences, Lahore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-03-30
Completion
2023-09-30

Countries

  • Pakistan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663268 on ClinicalTrials.gov