A Pilot Study in Severe Patients With Takayasu Arteritis.

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04300686
Phase
PHASE4
Status
Recruiting
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Conditions

  • Adalimumab
  • Takayasu Arteritis
  • Tocilizumab
  • Treatment

Eligibility Criteria

Sex
ALL
Age
14 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — BIOLOGICAL
    The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.
  • Adalimumab — BIOLOGICAL
    The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead.

Study Details

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.

Key Dates

Start date
Mar 1, 2020
Status verified
Aug 2021
Primary completion
May 1, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tocilizumab
    This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg/kg. qm. ivgtt.) for 24 weeks.
  • Experimental: Adalimumab
    This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.

Primary Outcome Measure

Disease remission at 24 weeks. [ Time Frame: 24 weeks ]

Central Contacts

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