Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Sponsor
Chinese SLE Treatment And Research Group
Study ID
NCT05151848
Phase
PHASE4
Status
Unknown

Conditions

  • Takayasu Arteritis

Eligibility Criteria

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

Interventions

Study Details

This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Key Dates

Start date
Jan 5, 2022
Status verified
Jul 2023
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026

Study Design

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

Arms

  • Experimental: Adalimumab group
    Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.
  • Active Comparator: Tofacitinib 5MG group
    Tofacitinib 5mg BID taken orally for 78 weeks.

Primary Outcome Measure

percentage of patients with complete response [ Time Frame: week 78 ]

Central Contacts

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