Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, Infliximab biosimilar, Efficacy, safety
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.
Interventions
BIOLOGICALInfliximab-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
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hidradenitis Suppurativa Clinical Response (HiSCR) | 24 weeks | 50% reduction in score |
| Dermatology Life Quality Index (DLQI) | 24 weeks | 50% reduction |
Countries
Pakistan
Outcome results
None listed