Comparing Baricitinib and Methotrexate for Treating Skin Tightening in Diffuse Cutaneous Systemic Sclerosis

What this Trial Is About

Diffuse cutaneous systemic sclerosis dcSSc is a serious autoimmune disease causing progressive skin tightening and organ damage. Researchers are comparing the effects of baricitinib, a Janus kinase inhibitor, with methotrexate, a commonly used drug, to assess their impact on skin tightening in patients with dcSSc. The study aims to evaluate the safety and effectiveness of baricitinib in this condition over a 24-week period. Participants will be randomly assigned to one of two groups one group will receive baricitinib 4 mg daily, while the other will take methotrexate 25 mg weekly along with folic acid 5 mg weekly. Both groups will be monitored closely with clinical assessments, laboratory tests, and chest X-rays at the start and during follow-up visits at 4, 12, and 24 weeks. The primary measure of success is the change in skin tightening as determined by the modified Rodnan skin score mRSS at 24 weeks. Throughout the study, participants will undergo evaluations including skin scoring, clinical disease activity index CDAI, blood tests, and imaging to track treatment response and side effects. Safety will be monitored by history, physical exams, and lab results. The study results will be analyzed statistically to compare the two treatments. Total participation lasts at least 24 weeks with scheduled follow-ups and laboratory monitoring to assess both efficacy and safety outcomes.

Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate