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

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Apr 12, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called baricitinib for patients with diffuse cutaneous systemic sclerosis (dcSSc), a condition that causes the skin to become increasingly tight and can lead to serious health issues. The trial compares baricitinib to another treatment called methotrexate, which is commonly used but doesn’t always work well for everyone. Eligible participants must have a confirmed diagnosis of dcSSc, have had the disease for less than five years, and have a certain level of skin involvement measured by a specific scoring system.

Participants in the trial will be divided into two groups: one will take baricitinib daily, while the other will take methotrexate weekly. Throughout the study, which lasts about six months, participants will have regular check-ups to monitor their skin condition and any possible side effects from the medication. The goal is to find out how well baricitinib works in improving skin tightness compared to methotrexate. If you or a loved one are interested in joining this study, it’s important to discuss eligibility requirements and potential benefits or risks with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of diffuse cutaneous systemic sclerosis, as classified using the 2013 American College of Rheumatology
• • 2. Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger 3. Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation) 4. mRSS score ≥ 10 at baseline
• Exclusion Criteria:
• Subjects with any of the following characteristics/conditions will not be included in the study:
• • 1. Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
• • 2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
• • 3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
• • 4. Any infected ulcer prior to treatment
• • 5. Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
• • 6. Oral corticosteroids \>10 mg/day of prednisone or equivalent.
• • 7. Mycophenolate mofetil \> 2 grams/day prior to baseline
• • 8. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
• • 9. Current clinical, radiographic, or laboratory evidence of active TB.
• • 10. Positive for hepatitis B surface antigen at or within 30 days of screening.
• • 11. Positive for hepatitis C antigen at or within 30 days of screening.
• • 12. Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
• • 13. Pregnant or breastfeeding female subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after discontinuation of study drug.
• • 14. History of any malignancy in the last 5 years
• • 15. History of SSc Renal Crisis within the 6 months prior to baseline.
• • 16. Patients with a history of anaphylaxis to Baricitinib or methotrexate
• 17. Any of the following lab results at screening:
• • Hemoglobin \<8 g/dl
• • White Blood Cell count \<3.0 x 109/L;
• • Absolute Neutrophil count \<1.2 x 109/L;
• • Platelet count \<100 x 109/L;
• • Absolute Lymphocyte count \<0.75 x 109/L.
• • ALT \> 3 × the upper limit of normal (ULN) of normal at screening
• • Estimated glomerular filtration rate \[GFR\] \<60mL/min/1.73 m2