Efficacy of Tofacitinib on Skin Thickening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT07472166
Phase
PHASE4
Status
Completed

Conditions

  • Scleroderma, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib: 5mg orally twice daily for 24 weeks
  • Methotrexate — DRUG
    25mg orally once weekly for 24 weeks

Study Details

This study aims to evaluate the efficacy of Tofacitinib compared to Methotrexate (MTX) in reducing skin thickening in patients with diffuse cutaneous systemic sclerosis (dcSSc). Systemic sclerosis is a chronic autoimmune disease characterized by skin fibrosis and internal organ involvement. Despite existing treatments, many patients continue to experience progressive skin and joint symptoms. Tofacitinib, a Janus kinase (JAK) inhibitor, has shown potential benefit in reducing inflammation and fibrosis in autoimmune diseases. This randomized controlled study will compare the change in Modified Rodnan Skin Score (mRSS), Clinical Disease Activity Index (CDAI), and 12-Item Short Form Survey (SF-12) between the Tofacitinib and Methotrexate groups over the study period. The study will also monitor adverse events and laboratory parameters to assess drug safety and tolerability.

Key Dates

Start date
Dec 21, 2024
Status verified
Mar 2025
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib group
  • Active Comparator: Methotrexate group

Primary Outcome Measure

Change in Modified Rodnan Skin Score (mRSS) from baseline to week 24 Scale range: 0 (no skin thickening) to 51 (most severe skin thickening) Higher score indicate worse skin thickening (worse outcome) [ Time Frame: Baseline and Week 24 ]

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