Baricitinib for Refractory Takayasu Arteritis (NCT06662721) | Clinical Trial Compass
CompletedPhase 2
Baricitinib for Refractory Takayasu Arteritis
China10 participantsStarted 2023-04-03
Plain-language summary
Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches. For TKA refractory to TNF-α, Baricitinib, a reversible inhibitor of Janus kinases (JAK) family members JKA1 and JAK2, represents a potential treatment option. This study aims to assess the efficacy and safety of Baricitinib in TKA refractory to TNF-α inhibitors.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Male or female aged 18-70 years at time of screening.
* Diagnosis of Takayasu arteritis (according to the 2022 ACR/EULAR) for ≥3 months before screening.
* Active Takayasu arteritis at time of screening (NIH score≥2).
* Resistant to traditional therapies and anti-TNF-α therapy for at least 12 months.
* Given their written informed consent to participate in the trial and expected to be able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
* TKA-related active major organ involvement requiring immunosuppressive therapy, e.g., pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis, recurrent malignant aneurysms), gastrointestinal (e.g., gastrointestinal ulcers), and central nervous system (e.g., meningoencephalitis).
* High-dose glucocorticoid (\>1mg/kg/d) usage within 1 month.
* Severe comorbidities: including heart failure (≥ grade III NYHA), renal insufficiency (creatinine clearance ≤30 ml/min), hepatic insufficiency (serum ALT or AST \>3 times the ULN, or total bilirubin \>ULN for the central laboratory conducting the test). Other severe, progressive or uncontrolled hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
* Known allergies, hypersensitivity, or intolerance to Baricitinib or its excipients.
* Had a severe infection (including, but not limited to hepatitis, pneumonia, sepsi…
What they're measuring
1
Patients achieving complete remission and partial remission