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Clinical trial

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

ID
Name
IRB/2022/101/SIMS
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
Trial arms
Trial start
2022-10-01
Estimated PCD
2023-03-30
Trial end
2023-09-30
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Patients of Hidradenitis suppurativa resistant to conventional therapy
Other names:
Remsima (infliximab-dyyb biosimilar)
Size
37
Primary endpoint
Hidradenitis Suppurativa Clinical Response (HiSCR)
24 weeks
Dermatology Life Quality Index (DLQI)
24 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Adult patients of either gender suffering from Hidradenitis suppurativa resistant to conventional therapies', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

1 product

1 indication

Organization
Services Institute of Medical Sciences
Product
Infliximab-dyyb
Indication
Hidradenitis Suppurativa