Iguratimod Combined With Tofacitinib in the Treatment of Rheumatoid Arthritis

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT05803135
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Iguratimod combined with Tofacitinib; — DRUG
    Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily); Placebo of Iguratimod (taken orally, 25mg, bid, daily) combined with Tofacitinib (taken orally, 5mg, bid, daily)

Study Details

The purpose of this study is to assess the efficacy and safety of Iguratimod combined with Tofacitinib in the treatment of csDMARD-IR patients with active moderate-to-severe rheumatoid arthritis

Key Dates

Start date
Mar 31, 2023
Status verified
Mar 2023
Primary completion
Jan 30, 2025
Completion
Dec 30, 2025

Study Design

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

Arms

  • Active Comparator: Double-Blind Iguratimod
    Iguratimod (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)
  • Placebo Comparator: Double-Blind Placebo
    Placebo (25mg twice daily) combined with Tofacitinib (5mg twice daily) for 24 weeks (6 months)

Primary Outcome Measure

The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28 [ Time Frame: week 24 ]

Related Studies