NCT03550781

Brief Summary

Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2018

Typical duration for phase_2

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

May 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

May 5, 2018

Last Update Submit

June 7, 2018

Conditions

Takayasu ArteritisAnti-Inflammatory Agents

Keywords

Takayasu ArteritisAnti-Inflammatory AgentsPositron Emission Tomography Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Lesion progression

    Progression of previous lesion degree\>20% or new lesion

    baseline and 12 months

Secondary Outcomes (8)

  • Lesion progression

    baseline, 3 months, 6 months, 9 months

  • Changes in plasma concentration of tumor necrosis factor

    baseline, 3 months, 6 months, 9 months and 12 months

  • Changes in plasma concentration of interleukin-2

    baseline, 3 months, 6 months, 9 months and 12 months

  • Changes in plasma concentration of interleukin-6

    baseline, 3 months, 6 months, 9 months and 12 months

  • Changes in plasma concentration of interleukin-8

    baseline, 3 months, 6 months, 9 months and 12 months

  • +3 more secondary outcomes

Study Arms (2)

Anti-inflammatory treatment group

EXPERIMENTAL

Prednisone and/or cyclophosphamide

Drug: Prednisone, cyclophosphamide

Control group

NO INTERVENTION

No intervention

Interventions

Prednisone, cyclophosphamideDRUG

Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

Anti-inflammatory treatment group

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
  • Inactive Takayasu arteritis according to National Institutes of Health criteria;
  • Age ≥ 14 and ≤ 40 years old at the time of informed consent;
  • Patients or guardian agree to participate in the study.

You may not qualify if:

  • Active Takayasu arteritis according to National Institutes of Health criteria;
  • Poor compliance, intolerance to or poor response to hormone therapy;
  • Allergy to contrast agent;
  • Renal insufficiency (serum creatinine \>133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase \>1.5 times upper limit of normal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

PrednisoneCyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Xiongjing Jiang, MD

    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

86-1088322385jxj103@hotmail.com

Hui Dong, MD

CONTACT

+8615810161393donghui666@sina.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2018

First Posted

June 8, 2018

Study Start

June 1, 2018

Primary Completion

May 31, 2020

Study Completion

May 31, 2021

Last Updated

June 8, 2018

Record last verified: 2018-06