A Phase 4 interventional study of Tripterygium Wilfordii and Methotrexate in Arthritis, Rheumatoid, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
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.
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:
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:
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 :
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 504 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treated with oral methotrexate and two placebos.
Drug: Methotrexate
Treated with oral Tripterygium Wilfordii and two placebos.
Drug: Tripterygium Wilfordii
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
Drug: Methotrexate · Drug: Yisaipu
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
Drug: Tripterygium Wilfordii · Drug: Yisaipu
Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.
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.
Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.
The American College of Rheumatology 50 (ACR50) response at 12 weeks
The difference of ACR50 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.
Time frame: week 12
The American College of Rheumatology 20/70 (ACR20/ACR70) response at 12 weeks
The difference of ACR20 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.
Time frame: week 12
The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks
The difference of ACR20, ACR50 and ACR70 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 24.
Time frame: week 24
The Disease Activity Score-28 (DAS28) response at 24 weeks
The change in DAS28 score from baseline to week 24 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX). DAS28 ＝ 0.56\*SQRT(TJC28) + 0.28\*SQRT(SJC28) + 0.36\*ln(CRP + 1) + 0.014\*GH + 0.96 * TJC28: The number of tender joints (0-28). * SJC28: The number of swollen joints (0-28). * CRP: The C-Reactive Protein level (in mg/l). * GH: The patient global health assessment (from 0=best to 100=worst). The 28 joint: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.
Time frame: week 24
The European League Against Rheumatism (EULAR) response at 12 weeks
The difference of proportions of patients meeting EULAR response between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.
Time frame: week 12
Health Assessment Questionnaire without Didability Index (HAQ-DI) at 12 weeks
The change in HAQ-DI score from baseline to week 12 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX). HAQ-DI is an index measuring the quality of life related to health, which includes 20 questions in terms of three categories: * from 0 to 1: mild difficulties to moderate disability, * from 1 to 2: disability moderate to severe, * from 2 to 3: severe to very severe disability. The mean score is recorded as the result.
Time frame: week 12
The Incidence of adverse events during 24-week study
Incidence of adverse events and sever adverse events (SAE), including hospitalized or Treatment-emergent adverse events, during 24-week study.
Time frame: week 24
Plan to share: Undecided
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Peking Union Medical College Hospital