Actively Recruiting
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Led by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Updated on 2025-04-20
24
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions. It is divided into two types, limited cutaneous systemic sclerosis (lcSSc) and diffuse cutaneous systemic sclerosis (dcSSCc). Skin involvement in systemic sclerosis is assessed by modified Rodnan skin score (mRSS). Methotrexate is a drug used in the treatment of skin tightening in SSc but has inconsistent response . Janus kinase (JAK) inhibitors are a class of drugs that may be used in skin involvement in dcSSc. Among them, baricitinib, a JAK 1/2 inhibitor, has shown some efficacy in dcSSc. The aim of this study is to assess the efficacy and safety of baricitinib on skin tightening in dcSSc patients. This open label randomized clinical trial will be conducted in department of rheumatology, BSMMU. Systemic sclerosis will be diagnosed by ACR/EULAR classification criteria 2013. Among them who have diffuse cutaneous involvement will be considered primary entry criteria for this study. Consecutive sampling method will be applied. Participants will be divided into two groups, group A and group B. Group A will be put on tab. baricitinib 4 mg daily and group B will be put on tab. methotrexate 25 mg weekly with folic acid 5 mg weekly. All participants will be assessed for mRSS, CDAI at baseline and laboratory tests like CBC, ESR, CRP, SGPT, serum creatinine, CXR P/A view etc. Follow up will be done at 4, 12, 24 weeks. Response to treatment will be assessed by modified Rodnan skin score. Primary endpoint of efficacy will be assessed by the end of 24th week. adverse effects will be assessed by history, physical examination and investigations. The data will be analyzed by SPSS version 25. results will be recorded using means and standard deviations. Result will be compared among groups with a 95% confidence interval and a p-value 0f\<0.05. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test for skewed distribution. Qualitative data in between groups will be analyzed by chi square test. Probabilities of association will be assessed by Spearman's rank correlation coefficient. P value of \< 0.05 will be regarded as statistically significant.
CONDITIONS
Official 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 using 2013 American College of Rheumatology criteria
- Diffuse cutaneous systemic sclerosis defined by 2001 LeRoy and Medsger
- Disease duration of 60 months or less since first non-Raynaud symptom
- Modified Rodnan skin score (mRSS) of 10 or higher at baseline
You will not qualify if you...
- Having rheumatic diseases other than systemic sclerosis, except fibromyalgia and scleroderma-associated myopathy
- Limited cutaneous systemic sclerosis or sine scleroderma at screening
- Major surgery within 8 weeks before screening
- Presence of any infected ulcer before treatment
- Serious bacterial infections such as chronic pyelonephritis, osteomyelitis, or bronchiectasis
- Taking oral corticosteroids over 10 mg/day prednisone or equivalent
- Using mycophenolate mofetil over 2 grams/day before baseline
- Pulmonary disease with forced vital capacity (FVC) 50% or less of predicted, or DLCO 40% or less of predicted
- Active tuberculosis based on clinical, radiographic, or lab evidence
- Positive hepatitis B surface antigen within 30 days of screening
- Positive hepatitis C antigen within 30 days of screening
- Uncontrolled significant diseases affecting kidneys, liver, blood, gastrointestinal system, metabolism, endocrine system, lungs, heart, or nervous system
- Pregnant or breastfeeding females or females unwilling/unable to use effective contraception as required
- History of any cancer in the 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, white blood cell count under 3.0 x 10^9/L, neutrophil count under 1.2 x 10^9/L, platelet count under 100 x 10^9/L, lymphocyte count under 0.75 x 10^9/L, ALT over 3 times upper limit of normal, or estimated glomerular filtration rate under 60 mL/min/1.73 m2
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Trial Site Locations
Total: 1 location
1
BSMMU
Dhaka, Bangladesh
Actively Recruiting
Research Team
D
Dr Md. Fahad Hossain, MBBS, MD
CONTACT
D
Dr Md. Ariful Islam, MBBS, MD, FCPS
CONTACT
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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