💬In plain words
What the trial is, and whether it could suit you
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 b
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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