NCT07472166

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Scleroderma, Systemic

Interventions

Type	Name	Description
DRUG	Tofacitinib	Tofacitinib: 5mg orally twice daily for 24 weeks
DRUG	Methotrexate	25mg orally once weekly for 24 weeks

Timeline

• Start date: 2024-12-21
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Bangladesh