Actively Recruiting
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis Compared to Methotrexate
Led by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Updated on 2025-04-20
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diffuse cutaneous systemic sclerosis according to 2013 ACR/EULAR criteria
- Diffuse cutaneous systemic sclerosis as defined by 2001 LeRoy and Medsger
- Disease duration of 60 months or less from first non-Raynaud symptom
- Modified Rodnan skin score (mRSS) of 10 or higher at baseline
You will not qualify if you...
- Rheumatic diseases other than systemic sclerosis (except fibromyalgia and scleroderma-associated myopathy)
- Limited cutaneous systemic sclerosis or sine scleroderma
- Major surgery within 8 weeks before screening
- Any infected ulcer before treatment
- Serious bacterial infections like chronic pyelonephritis, osteomyelitis, or bronchiectasis
- Use of oral corticosteroids over 10 mg/day prednisone or equivalent
- Use of mycophenolate mofetil over 2 grams/day before baseline
- Pulmonary disease with FVC 50% or less or DLCO 40% or less predicted
- Active tuberculosis clinically, radiographically, or by lab tests
- Positive hepatitis B surface antigen within 30 days of screening
- Positive hepatitis C antigen within 30 days of screening
- Uncontrolled significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurologic diseases
- Pregnant or breastfeeding women or those unwilling or unable to use effective contraception during and 28 days after study
- History of malignancy within last 5 years
- History of systemic sclerosis renal crisis within 6 months before baseline
- History of anaphylaxis to baricitinib or methotrexate
- Lab abnormalities at screening including hemoglobin below 8 g/dl, low white blood cells, neutrophils, platelets, lymphocytes, ALT over 3 times normal, or estimated GFR below 60 mL/min/1.73 m2
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either baricitinib 4 mg daily or methotrexate 25 mg weekly with folic acid 5 mg weekly to evaluate effects on skin tightening in diffuse cutaneous systemic sclerosis.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 1 location
1
BSMMU
Dhaka, Bangladesh
Actively Recruiting
Research Team
D
Dr Md. Fahad Hossain, MBBS, MD
D
Dr Md. Ariful Islam, MBBS, MD, FCPS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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