Effectiveness of Tofacitinib in Systemic Sclerosis

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT06044844
Phase
PHASE2
Status
Unknown

Conditions

  • Efficacy of Tofacitinib in the Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to compare efficacy of tofacitinib with cyclophosphamide in skin thickening in early diffuse cutaneous systemic sclerosis .

Key Dates

Start date
Nov 30, 2023
Status verified
Sep 2023
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efficacy of tofacitinib in early diffuse cutaneous systemic sclerosis
    tab tofacitinib 5mg twice daily will be given by oral route for 6month
  • Experimental: efficacy of Cyclophosphamide in early diffuse cutaneous systemic sclerosis
    injection cyclophosphamide 500mg/m2 body surface area/monthly by intravenous infusion.total 6cycle will be given

Primary Outcome Measure

skin thickness [ Time Frame: 24 weeks after initiation of treatment ]

Central Contacts