CompletedNot Applicable

Takayasu Arteritis Clinical Trial in China

China116 participantsStarted 2016-12-22

Plain-language summary

To investigate the efficacy and safety of Leflunomide (LEF) versus placebo combined with prednisone for active Takayasu arteritis (TAK) in Chinese population.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. new vascular ischemic manifestations/physical signs or systemic symptoms;
✓. evaluated erythrocyte sedimentation rate (ESR) or high-sensitivity C reactive protein (hs-CRP) ≥6 mg/L or C reactive protein (CRP) ≥10 mg/L without other confounding factors (e.g., infection);
✓. active vascular inflammation as indicated by contrast-enhanced computed tomography angiography (CTA), magnetic resonance angiography (MRA), color Doppler ultrasonography or positron emission tomography/CT (PET/CT); iii. Individuals should not receive LEF within 3 months before screening; iv. For individuals who received cyclophosphamide before screening, cyclophosphamide should be discontinued for ≥8 weeks; for patients who received a biological agent before screening, biological agents (e.g., tocilizumab, rituximab, and inhibitors of tumor necrosis factor) should be discontinued for ≥12 weeks; v. For patients who were taking prednisone (or its equivalent) before screening, the dose should be ≤0.6 mg/kg/day and the dose should be stable for ≥4 weeks; vi. Pregnancy should not be planned and a pregnancy test should be negative.

Exclusion criteria

✕. heart dysfunction: New York Heart Association grade IV;
✕. renal dysfunction: estimated glomerular filtration rate ≤60 mL/min;
✕. liver dysfunction: Child-Pugh grade ≥2;
✕. neurologic severe ischemic event: amaurosis on 3 consecutive days, acute cerebral infarction, or cerebral hemorrhage;
✕. uncontrolled blood pressure \>160/100 mmHg; iv. Individuals had at least one following abnormal laboratory test results:
✕. previous treatment with LEF for ≥3 months but not efficacious;
✕. planning to receive an attenuated vaccine during the study period;
✕. planning to undergo (or have undergone) organ transplantation.

What they're measuring

Achievement of clinical remission at week 24

Timeframe: From the date of randomization until the end of induced remission therapy, assessed up to 24 weeks

Trial details

NCT IDNCT02981979

SponsorJiang lindi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-22

View on ClinicalTrials.gov More Takayasu Arteritis trials