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ADATOFTAK: Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Sponsor
Chinese SLE Treatment And Research Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT05151848
Collaborator
(none)
100
Enrollment
4
Locations
2
Arms
36.3
Anticipated Duration (Months)
25
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Adalimumab Injection
  • Drug: Tofacitinib 5 MG
 Phase 4

Detailed Description

In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 52.

The efficacy will be evaluated at week 12, 24, 36 and 52. If the patient does not respond to one drug at week 12,then the investigator will shift the treatment to another intervention.Safety is also monitored during the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
open-label, multicenter,randomized trialopen-label, multicenter,randomized trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Actual Study Start Date :
Jan 5, 2022
Anticipated Primary Completion Date :
Jan 15, 2025
Anticipated Study Completion Date :
Jan 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adalimumab group

Adalimumab 40mg injected subcutaneously every 2 weeks for 52 weeks.

Drug: Adalimumab Injection
Adalimumab Injection injected subcutaneously every other week for 52 weeks
Other Names:
  • An-jian-ning

    		•
    Active Comparator: Tofacitinib 5MG group

    Tofacitinib 5mg BID taken orally for 52 weeks.

    Drug: Tofacitinib 5 MG
    Tofacitinib 5 MG BID taken orally for 52 weeks
    Other Names:
  • An-shu-zheng

    		•

    Outcome Measures

    Primary Outcome Measures

    1. percentage of patients with complete response [week 52]

      percentage of patients with complete response at week 52

    Secondary Outcome Measures

    1. percentage of patients with partial response [week 52]

      percentage of patients with partial response at week 52

    2. Percentage of patients with image progression at the end of study [week 52]

      percentage of patients with progress disease demonstrated by CTA or Doppler at week 52

    3. adverse events [52 weeks]

      safety profile of both Adalimumab and Tofacitinib treatment group

    4. intervention procedures [52 weeks]

      percentage of patients who require intervention procedures during the study period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients aged between 18-65 years old;

    2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;

    3. relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;

    4. Patients who signed the informed consent form. -

    Exclusion Criteria:

    1. Patients who failed or intolerant to either adalimumab or tofacitinib;

    2. patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;

    3. not well controlled diabetes;

    4. uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);

    5. Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;

    6. upper GI bleeding 3 months before enrolement;

    7. refractory hypertension;

    8. Pregnant or intended to be pregnant 3 months after the trial;

    9. Severe coronary artery involvement demonstrated by CTA;

    10. severe cranial or cervical or renal artery diseases that need surgery;

    11. Patients that should not be included by the investigator. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Anzhen Hospital Beijing China 100000
    2 The General Hospital of the People's Liberation Army Beijing China 100000
    3 Beijing Shijitan Hospital Beijing China 100053
    4 Beijing Xuanwu Hospital Beijing China 100053

    Sponsors and Collaborators

    • Chinese SLE Treatment And Research Group

    Investigators

    • Principal Investigator: Xiaofeng Zeng, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinping Tian, Professor of Medicine, Chinese SLE Treatment And Research Group
    ClinicalTrials.gov Identifier:
    NCT05151848
    Other Study ID Numbers:
    • CSTAR-007
    First Posted:
    Dec 9, 2021
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arteritis
    Takayasu Arteritis
    Aortic Arch Syndromes
    Adalimumab
    Tofacitinib

    Study Results

    No Results Posted as of Mar 2, 2022