Upadacitinib for Refractory Takayasu Arteritis (NCT07500467) | Clinical Trial Compass
CompletedNot Applicable
Upadacitinib for Refractory Takayasu Arteritis
China12 participantsStarted 2024-03-19
Plain-language summary
Takayasu arteritis (TKA) is an autoimmune vasculitis characterized with involvement of aorta and its primary branches.Upadacitinib is an oral, selective JAK1 inhibitor that potently inhibits JAK1 activity, representing a potential therapeutic option.This study aims to assess the efficacy and safety of upadacitinib in refractory Takayasu arteritis.
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 6 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, sepsis, or pyelon…
What they're measuring
1
Patients achieving complete remission and partial remission
Timeframe: 24 weeks
2
The primary endpoint was defined as the proportion(percent) of patients in the whole cohort achieving complete remission and partial remission by week 24.