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A Pilot Study in Severe Patients With Takayasu Arteritis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300686
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Takayasu Arteritis Tocilizumab Adalimumab Treatment Biological: Tocilizumab Biological: Adalimumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Severe TAK patients were divided into two groups, with 20 cases for each group at the randomized ratio 1:1, prescribed with adalimumab (40mg.bim.IH) and tocilizumab (8mg/kg.qm.ivgtt) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated (remission), the strategy would be maintained for another 24weeks, otherwise (resistant), the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint).
Masking: None (Open Label)
Masking Description: None. Open-label.
Primary Purpose: Treatment
Official Title: A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tocilizumab
This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg/kg. qm. ivgtt.) for 24 weeks.
Biological: Tocilizumab

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.

Other Name: IL-6R alpha antibody

Experimental: Adalimumab
This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.
Biological: Adalimumab

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.

Other Name: TNF-alpha antibody




Primary Outcome Measures :
  1. Disease remission at 24 weeks. [ Time Frame: 24 weeks ]
    comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up;


Secondary Outcome Measures :
  1. Disease remission at 48 weeks. [ Time Frame: 48 weeks ]
    comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 48th week follow-up;

  2. Prednisone dose reduction at endpoint [ Time Frame: 24 weeks and 48 weeks. ]
    comparison of targeted prednisone usage between adalimumab and tocilizumab groups at the end of 24th and 48th week follow-up;

  3. disease relapse in the follow-up [ 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. ]
    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.)

  4. Vascular progression in angiographic examination at 6 months and 12 months. [ Time Frame: 24 weeks and 48 weeks. ]
    comparison of vascular change with MRA, CTA, or doppler ultrasound angiographic examinations between adalimumab and tocilizumab groups;

  5. Change of the quality of life with questionnaire SF-36 [ 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. ]
    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)

  6. Change of the quality of life with questionnaire MOS-sleep scale [ 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. ]
    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)

  7. Change of the quality of life with the Fatigue severity scale [ 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. ]
    comparison of quality of life between adalimumab and tocilizumab groups with the Fatigue severity scale (Scores: 9-63, higher score means severe fatigue)



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Ages Eligible for Study:   14 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300686


Contacts
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Contact: Rongyi Chen, PhD +8615221160538 chenry825@hotmail.com
Contact: Lili Ma, PhD +8615221160538 zsh-rheum@hotmail.com

Locations
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China, Shanghai
Department of Rheumatology in Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Lindi Jiang, PhD    +86-021-64041990    zsh-rheum@hotmail.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Lindi Jiang, PhD Fudan University
  Study Documents (Full-Text)

Documents provided by Shanghai Zhongshan Hospital:
Study Protocol  [PDF] November 10, 2020

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04300686    
Other Study ID Numbers: TACTIC-SS
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shanghai Zhongshan Hospital:
Takayasu Arteritis
Tocilizumab
Adalimumab
treatment
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Adalimumab
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents