NCT05151848

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

4 years

First QC Date

November 6, 2021

Last Update Submit

July 21, 2023

Conditions

Takayasu Arteritis

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with complete response

    percentage of patients with complete response at week 78

    week 78

Secondary Outcomes (4)

  • percentage of patients with partial response

    week 78

  • Percentage of patients with image progression at the end of study

    week 78

  • adverse events

    78 weeks

  • intervention procedures

    78 weeks

Study Arms (2)

Adalimumab group

EXPERIMENTAL

Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.

Drug: Adalimumab Injection

Tofacitinib 5MG group

ACTIVE COMPARATOR

Tofacitinib 5mg BID taken orally for 78 weeks.

Drug: Tofacitinib 5 MG

Interventions

Adalimumab InjectionDRUG

Adalimumab Injection injected subcutaneously every other week for 78 weeks

Also known as: An-jian-ning
Adalimumab group
Tofacitinib 5 MGDRUG

Tofacitinib 5 MG BID taken orally for 78 weeks

Also known as: An-shu-zheng
Tofacitinib 5MG group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18-65 years old;
  • Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
  • relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
  • Patients who signed the informed consent form.

You may not qualify if:

  • Patients who failed or intolerant to either adalimumab or tofacitinib;
  • patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
  • not well controlled diabetes;
  • uncontrolled heart failure od renal dysfunction(eGFR\<30ml/min);
  • Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
  • upper GI bleeding 3 months before enrolement;
  • refractory hypertension;
  • Pregnant or intended to be pregnant 3 months after the trial;
  • Severe coronary artery involvement demonstrated by CTA;
  • severe cranial or cervical or renal artery diseases that need surgery;
  • Patients that should not be included by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Anzhen Hospital

Beijing, 100000, China

RECRUITING

The General Hospital of the People's Liberation Army

Beijing, 100000, China

NOT YET RECRUITING

Beijing Shijitan Hospital

Beijing, 100053, China

NOT YET RECRUITING

Beijing Xuanwu Hospital

Beijing, 100053, China

NOT YET RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

Adalimumabtofacitinib

Condition Hierarchy (Ancestors)

Aortic Arch SyndromesAortic DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Xiaofeng Zeng, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian, MD

CONTACT

8613691165939tianxp6@126.com

Yunjiao Yang, MD

CONTACT

8613671313079yangyunjiao81@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: open-label, multicenter,randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 9, 2021

Study Start

January 5, 2022

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)