NCT03589833

Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA

Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis.

Detailed description

This study evaluates the efficacy and safety of YISAIPU plus Tripterygium wilfordii (T2w) for the treatment of RA patients. YISAIPU is a recombinant human tumor necrosis factor receptor fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of Tripterygium wilfordii Hook F. Objectives: 1. To compare the efficacy of YISAIPU plus T2w versus MTX monotherapy for the treatment of signs and symptoms of RA. 2. To evaluate the safety of YISAIPU plus T2w in patients with RA for 24 weeks. Design: This is a randomized, 24-week, double-blind, parallel group study, and 506 patients with active RA will be randomized in a 1:1:1:1 ratio to one of the following four parallel treatment arms: 1. Methotrexate monotherapy 2. T2w monotherapy 3. YISAIPU plus methotrexate 4. YISAIPU plus T2w Escape: On week 13, all participants with inadequate response, defined as a \<30% improvement of swollen and tender joint counts from baseline, will switch to YISAIPU plus T2w treatment throughout the study. Endpoints : 1. ACR20, ACR50 and ACR70 response rates at 12 and 24 weeks. 2. DAS 28 (CRP) and DAS 28 (ESR) at 12 and 24 weeks. 3. EULAR response rates at 12 and 24 weeks. 4. Health assessment questionnaire (HAQ) at 12 and 24 weeks. 5. Patient assessment of arthritis pain at 12 and 24 weeks. 6. Patient and physician global assessment of arthritis at 12 and 24 weeks.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Tripterygium Wilfordii	Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.
DRUG	Methotrexate	Oral methotrexate 7.5-15mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 15mg (max 0.3mg/Kg) per week in 4 weeks. Folic acid at the dose of 5 mg per week were applied to all participants.
DRUG	Yisaipu	Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.

Timeline

• Start date: 2019-05-14
• Primary completion: 2022-03-20
• Completion: 2022-07-27
• First posted: 2018-07-18
• Last updated: 2022-10-25

Locations

1 site across 1 country: China