Clinical trial · Interventional
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
NCT03589833CI-TRIAL-00061673YISTARcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis, Rheumatoid | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| Tripterygium Wilfordii | Drug | — | UNRESOLVED |
| Yisaipu | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- MTX
- description
- Treated with oral methotrexate and two placebos.
- interventionNames
- Drug: Methotrexate
- type
- PLACEBO_COMPARATOR
- label
- Tripterygium Wilfordii
- description
- Treated with oral Tripterygium Wilfordii and two placebos.
- interventionNames
- Drug: Tripterygium Wilfordii
- type
- ACTIVE_COMPARATOR
- label
- Yisaipu + MTX
- description
- Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-65 years with informed consent * Diagnosis of rheumatoid arthritis (according to 2010 ACR/EULAR classification criteria) * Disease duration \> 6 weeks * Swollen joint (SJC)≥4 and tender joint count(TJC)≥4 * ESR \>28 mm/hr or C-reactive protein \> 1.5 ULN * Positive RF or anti-CCP antibody on screening * Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA * No evidence of active or latent or inadequately treated Mycobacterium tuberculosis infection Exclusion Criteria: * Pregnant, lactating or further fertility requirements * Previously received any biologic agents. * Recently (\<12 weeks) received methotrexate, leflunomide, salazosulfapyridine, azathioprine, cyclosporine, mycophenolate mofetil or Tripterygium Wilfordii. * Active or chronic infection, including HIV, HCV, HBV, tuberculosis. * History of any other rheumatic autoimmune disease * History of any lymphoproliferative disorder * Malignancy or history of malignancy. * Abnormal laboratory tests, including: Hemoglobin \<8.5 g/dL, White blood cell count \<3.5 x 109/L, Platelet count \<100 x 109/L, AST/ALT \>1.5 ULN, and serum creatine \> 1.5 mg/dL. * Severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease
References
Publications (1)
- DERIVEDZhang X, Yang H, Zuo X, Wu L, Peng J, Li Z, Li H, Ji W, Zhang L, Li X, Dai L, Lu L, Yang N, Wei W, Shuai Z, Jiang Y, Liu Y, Lipsky PE, Chen H; YISTAR study group. Efficacy and safety of tripterygium wilfordii Hook F plus TNF inhibitor for active rheumatoid arthritis: A multicentre, randomized, double-blind, triple-dummy controlled trial. Clin Immunol. 2023 Oct;255:109749. doi: 10.1016/j.clim.2023.109749. Epub 2023 Aug 30. PMID 37657525