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

Sponsor
Chinese SLE Treatment And Research Group
Study ID
NCT05749666
Phase
PHASE3
Status
Unknown

Conditions

  • Takayasu Arteritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5 MG — DRUG
    Tofacitinib 5 MG BID taken orally for 24 weeks
  • Prednisolone — DRUG
    Prednisolone taken daily according to preset tapering protocol
  • Placebo of tofacitinib 5mg — OTHER
    Placebo of tofacitinib 5mg BID taken orally for 24 weeks
  • Placebo of prednisolone — OTHER
    Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks

Study Details

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.

Key Dates

Start date
Jan 20, 2023
Status verified
Feb 2023
Primary completion
Jul 20, 2025
Completion
Jul 20, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib group
    Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
  • Active Comparator: Prednisolone group
    Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks

Primary Outcome Measure

Percentage of patients with complete response [ Time Frame: week 24 ]

Central Contacts

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