The Registry Study of Takayasu Arteritis in East China

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT03893136
Status
Unknown

Conditions

  • Mechanisms, Defense
  • Outcome
  • Pregnancy Related
  • Takayasu Arteritis
  • Treatment Refusal

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — BIOLOGICAL
    The scramble TA group is given bioagents such as IL-6R antibody, CD20-antibody, TNF-alpha antibody, and other bioagents which are safe to use in human to treat other refractory diseases. The sham group is given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.
  • Leflunomide — DRUG
    The scramble TA group is given new molecules such as Leflunomide, Iguratimod, and other molecules which are safe to use in human to treat other refractory diseases. The sham group is also given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.

Study Details

The Takayasu arteritis (TA) is a rare inflammatory large vessel arteritis which often occurs women in Aisa, one of which is China. The rare cases restricted the development of intervention strategy, especially in female patients who plan to be pregnant. So investigators try to recruit as many TA participants as possible to build a TA cohort so that investigators could manage patients much more professionally and standardized and explore the better interventional strategy for a better outcome as well, with full use of blood and vascular tissues.

Key Dates

Start date
Nov 1, 2016
Status verified
Aug 2021
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Control group
    The control group mainly consists of healthy volunteers. The whole blood is obtained and frozen to detect the corresponding biochemical markers in the futures. The vascular tissues are obtained from the deserted and free abdominal aorta conjugated to the renal artery in the kidney transplantation.
  • Arm: sham TA group
    In the TA cohort, patients are divided into two groups mainly, sham TA group and scramble TA group. The sham TA group is the TA group who is given the traditional and classical intervention or treatment and so on.
  • Arm: scramble TA group
    Compared to sham TA group in the cohort, scramble TA group refers to TA patients who are given novel drugs or new drugs which are safe to treat other autoimmune diseases but have not been used to treat TA yet, or some new interventions and so on.

Primary Outcome Measure

The change of manifestations of systemic symptom - fever [ Time Frame: Through study completion, an average of 2 months. ]

Central Contacts

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