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A Pilot Study in Severe Patients With Takayasu Arteritis.

ConditionsTakayasu ArteritisTocilizumabAdalimumabTreatment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-100
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age≥14 years old;

active: Kerr score≥ 2;

Blood pressure > 180/110mmHg;

≥ 3 branches with the stenotic rate > 70% involved;

Disqualifiers

Severe organ insufficiency;

Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;

Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;

malignant tumors;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tocilizumab

    Biological/Vaccine

    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/Vaccine

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: TocilizumabActive comparator 1 intervention
Group B: AdalimumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease remission at 24 weeks.

comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up;

Time frame
24 weeks

Secondary outcomes

1

Disease remission at 48 weeks.

comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 48th week follow-up;

Time frame
48 weeks
2

Prednisone dose reduction at endpoint

comparison of targeted prednisone usage between adalimumab and tocilizumab groups at the end of 24th and 48th week follow-up;

Time frame
24 weeks and 48 weeks.
3

disease relapse in the follow-up

comparison of disease relapse between adalimumab and tocilizumab groups; (Relapse is defined as: (1) Major relapse: Major relapse Recurrence of active disease with either of the following: a. Clinical features of ischaemia\* (including jaw claudication,visual symptoms, visual loss attributable to TAK, scalp necrosis, stroke, limb claudication). b. Evidence of active aortic inflammation resulting in progressive aortic or large vessel dilatation, stenosis or dissection. (2) Minor relapse: Recurrence of active disease, not fulfilling the criteria for a major relapse.)

Time frame
At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.
4

Vascular progression in angiographic examination at 6 months and 12 months.

comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between adalimumab and tocilizumab groups;

Time frame
24 weeks and 48 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov
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