Treatment Clinical Trial
Official title:
A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2023 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. age=14 years old; 2. active: Kerr score= 2; 3. severe: 1. Blood pressure > 180/110mmHg; 2. = 3 branches with the stenotic rate > 70% involved; 3. high degree of organ insufficiency: NYHF III~IV; eGFR (MRDR) 15~ 60ml/min; Exclusion Criteria: 1. Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients) |
Country | Name | City | State |
---|---|---|---|
China | Department of Rheumatology in Zhongshan hospital, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease remission at 24 weeks. | comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up; | 24 weeks | |
Secondary | Disease remission at 48 weeks. | comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 48th week follow-up; | 48 weeks | |
Secondary | 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; | 24 weeks and 48 weeks. | |
Secondary | 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.) | At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. | |
Secondary | 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; | 24 weeks and 48 weeks. | |
Secondary | Change of the quality of life with questionnaire SF-36 | comparison of quality of life between adalimumab and tocilizumab groups with the 36-Item Short Form Health Survey questionnaire (SF-36) (Scores:0~100, lower score means more disability) | At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. | |
Secondary | Change of the quality of life with questionnaire MOS-sleep scale | comparison of quality of life between adalimumab and tocilizumab groups with the questionnaire of sleep scale from medical outcomes study (MOS-sleep scale) (Scores: 11-65, lower scores indicates more difficulty in sleep) | At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. | |
Secondary | Change of the quality of life with the Fatigue severity scale | comparison of quality of life between adalimumab and tocilizumab groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue) | At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks. |
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