NCT05749666

Brief Summary

This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of 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
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.5 years

First QC Date

February 19, 2023

Last Update Submit

February 19, 2023

Conditions

Takayasu Arteritis

Keywords

Tofacitinibprednisolone

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with complete response

    Percentage of patients with complete response at week 24

    week 24

Secondary Outcomes (7)

  • Percentage of patients with partial response

    week 24

  • Percentage of patients with adverse events due to treatment of tofacitinib

    24 weeks

  • Percentage of patients with adverse events due to treatment of prednisolone

    24 weeks

  • Percentage of patients with progression, no change, and improvement in vessel image at the end of study

    week 24

  • Intervention procedures

    24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Tofacitinib group

EXPERIMENTAL

Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period

Drug: Tofacitinib 5 MGOther: Placebo of prednisolone

Prednisolone group

ACTIVE COMPARATOR

Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks

Drug: PrednisoloneOther: Placebo of tofacitinib 5mg

Interventions

Tofacitinib 5 MGDRUG

Tofacitinib 5 MG BID taken orally for 24 weeks

Tofacitinib group
PrednisoloneDRUG

Prednisolone taken daily according to preset tapering protocol

Prednisolone group
Placebo of tofacitinib 5mgOTHER

Placebo of tofacitinib 5mg BID taken orally for 24 weeks

Prednisolone group
Placebo of prednisoloneOTHER

Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks

Tofacitinib 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;
  • Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
  • Patients who signed the informed consent form.

You may not qualify if:

  • Patients who failed or intolerant to either tofacitinib or its similar drugs;
  • Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
  • Not well controlled diabetes;
  • Moderate and severe hyperlipedimia;
  • Patients with history of thrombus;
  • Uncontrolled heart failure od renal dysfunction (eGFR \<30ml/min);
  • Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
  • Upper GI bleeding happened in 3 months before enrollment;
  • Refractory hypertension;
  • Pregnant or intended to be pregnant recently;
  • Severe coronary artery involvement demonstrated by CTA;
  • Severe cranial or cervical or renal artery diseases that need surgery;
  • Patients that should not be included judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

tofacitinibPrednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xinping Tian, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinping Tian, MD

CONTACT

+86-13691165939tianxp6@126.com

Jing Li, MD

CONTACT

+86-13020061363lijing6515@pumch.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

January 20, 2023

Primary Completion

July 20, 2025

Study Completion

July 20, 2025

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

CN(1)