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Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

NCT04299971 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-06-12

No results posted yet for this study

Summary

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Here we tried to classify TAK patients in 3 levels, including mild, moderate, and severe, and prescribe methotrexate and tofacitinib randomly in mild and moderate patients, to observe the relatively better treatment strategy, facilitating better intervention strategy in TAK patients.

Conditions

  • Takayasu Arteritis
  • Methotrexate
  • Inhibition
  • Treatment

Interventions

DRUG

Methotrexate Tablets

The methotrexate group is prescribed with methotrexate Tablets 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, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead.

DRUG

Tofacitinib tablet

The tofacitinib group is prescribed with tofacitinib tablets 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, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Lindi Jiang, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04299971 on ClinicalTrials.gov