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Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

NCT05749666 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-01

No results posted yet for this study

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.

Conditions

  • Takayasu Arteritis

Interventions

DRUG

Tofacitinib 5 MG

Tofacitinib 5 MG BID taken orally for 24 weeks

DRUG

Prednisolone

Prednisolone taken daily according to preset tapering protocol

OTHER

Placebo of tofacitinib 5mg

Placebo of tofacitinib 5mg BID taken orally for 24 weeks

OTHER

Placebo of prednisolone

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

Sponsors & Collaborators

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Xinping Tian, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2025-07-20
Completion
2025-07-20

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 NCT05749666 on ClinicalTrials.gov