To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05606107
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib combined with other csDMARDs, but no glucocorticoids.
  • Glucocorticoid — DRUG
    Glucocorticoid

Study Details

Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.

Key Dates

Start date
May 20, 2022
Status verified
Oct 2022
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Active Comparator: Glucocorticoid group
  • Experimental: Tofacitinib group

Primary Outcome Measure

DAS28-CRP [ Time Frame: 24 weeks ]

Central Contacts

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