Trials / Completed
CompletedNCT05663268
Efficacy and Safety of Infliximab Biosimilar in the Treatment of Resistant Hidradenitis Suppurativa
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Services Institute of Medical Sciences, Pakistan · Other Government
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2023-03-30
- Completion
- 2023-09-30
- First posted
- 2022-12-23
- Last updated
- 2023-11-29
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT05663268. Inclusion in this directory is not an endorsement.