Clinical trial NCT05663268: Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
Official title: Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa
Infliximab biosimilar
Efficacy
safety
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2022-12-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Primary purpose: TREATMENT

Brief 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

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.

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
* hypersensitivity to biologics

Primary outcomes:
measure: Hidradenitis Suppurativa Clinical Response (HiSCR)
timeFrame: 24 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences, Lahore
name: Hira Tariq, FCPS Derma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.
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.