Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
NCT ID: NCT05663268
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
37 participants
INTERVENTIONAL
2022-10-01
2023-09-30
Brief Summary
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* 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
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with connective tissue disorders
* patients having chronic infections like heapatitis, HIV or Tuberculosis
* Pregnant or lactating mothers
* hypersensitivity to biologics
18 Years
60 Years
ALL
No
Sponsors
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Services Institute of Medical Sciences, Pakistan
OTHER_GOV
Responsible Party
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Hira Tariq
Principal Investigator
Principal Investigators
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Hira Tariq, FCPS Derma
Role: PRINCIPAL_INVESTIGATOR
Services Institute of Medical Sciences, Lahore
Locations
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Services Institute of Medical Sciences
Lahore, Punjab Province, Pakistan
Countries
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References
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Fernandez-Vozmediano JM, Armario-Hita JC. Infliximab for the treatment of hidradenitis suppurativa. Dermatology. 2007;215(1):41-4. doi: 10.1159/000102032.
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.
Other Identifiers
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IRB/2022/101/SIMS
Identifier Type: -
Identifier Source: org_study_id