Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT04299971
Phase
PHASE4
Status
Unknown

Conditions

  • Inhibition
  • Methotrexate
  • Takayasu Arteritis
  • Treatment

Eligibility Criteria

Sex
ALL
Age
14 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate Tablets — DRUG
    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.
  • Tofacitinib tablet — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2020
Status verified
Mar 2020
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: methotrexate
    This group of 38 TAK cases are prescribed with methotrexate tablets (Dose: 15.0 mg. qw. p.o.) for 24 weeks.
  • Experimental: Tofacitinib
    This group of 38 TAK cases are prescribed with tofacitinib tablets (Dose: 5.0 mg. bid. p.o.) for 24 weeks.

Primary Outcome Measure

Disease remission at 24 weeks. [ Time Frame: 24 weeks ]

Central Contacts

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