Status:
RECRUITING
Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Diffuse Cutaneous Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, l...
Eligibility Criteria
Inclusion
- 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
- Subjects with any of the following characteristics/conditions will not be included in the study:
- Rheumatic disease other than systemic sclerosis. it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
- Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit
- Major surgery (including joint surgery) within 8 weeks prior to screening visit
- Any infected ulcer prior to treatment
- Subjects with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
- Oral corticosteroids \>10 mg/day of prednisone or equivalent.
- Mycophenolate mofetil \> 2 grams/day prior to baseline
- Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin) ≤ 40% of predicted
- Current clinical, radiographic, or laboratory evidence of active TB.
- Positive for hepatitis B surface antigen at or within 30 days of screening.
- Positive for hepatitis C antigen at or within 30 days of screening.
- Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
- 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.
- History of any malignancy in the last 5 years
- History of SSc Renal Crisis within the 6 months prior to baseline.
- Patients with a history of anaphylaxis to Baricitinib or methotrexate
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06936215
Start Date
January 1 2024
End Date
May 1 2025
Last Update
April 20 2025
Active Locations (1)
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1
BSMMU
Dhaka, Bangladesh