NCT06146972

Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Yanfeng Hou · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.

Detailed description

This is an open, controlled, interventional clinical study enrolling patients with active RA who meet the following entry row criteria, and treating patients with IGU 25 mg bid + tofacitinib 5 mg bid for the intervention. The screening period was defined as the screening visit was conducted within 1 month prior to the baseline visit, and efficacy and safety assessments were performed at time points 0, 4, 12, 18, and 24 weeks from the time the subject was treated with the study protocol (see efficacy and safety endpoints for details), and study subjects were asked to come to the hospital for follow-up within ±3 days of the corresponding follow-up point.

Conditions

• Rheumatoid Arthritis
• Therapy

Interventions

Type	Name	Description
DRUG	Iguratimod	Iguratimod 25mg bid + tofacitinib 5mg bid

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-03-24
• Completion: 2024-05-31
• First posted: 2023-11-27
• Last updated: 2024-03-25

Locations

1 site across 1 country: China