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Tests treatment safety and results for Diffuse Cutaneous Systemic Sclerosis
Official title Safety and Efficacy of Baricitinib on Skin Tightening in Diffuse Cutaneous Systemic Sclerosis: A Comparative Study With Methotrexate
ClinicalTrials.gov ID: NCT06936215
What this study is testing
What is tab baricitinib 4 mg daily?
tab baricitinib 4 mg daily is an investigational medicine, given as an once-weekly, being studied as a potential treatment for diffuse cutaneous systemic sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Systemic sclerosis (SSc) is a systemic autoimmune disease. It causes progressive skin tightening, pulmonary fibrosis, organ damage and many other physical dysfunctions.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- people 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
- people with any serious bacterial infection (e.g.,chronic pyelonephritis, osteomyelitis, or bronchiectasis) .
See the full eligibility 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
- people 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
- people 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 people and female people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.