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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2022
• Main ID: NCT03589833
• Date of registration: 05/07/2018
• Prospective Registration: Yes
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA YISTAR
• Scientific title: Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis
• Date of first enrolment: May 14, 2019
• Target sample size: 504
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03589833
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Xuan Zhang, MD
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Methotrexate

Drug: Tripterygium Wilfordii

Drug: Yisaipu

Primary Outcome(s)

The American College of Rheumatology 50 (ACR50) response at 12 weeks [Time Frame: week 12]

Secondary Outcome(s)

Health Assessment Questionnaire without Didability Index (HAQ-DI) at 12 weeks [Time Frame: week 12]

The Disease Activity Score-28 (DAS28) response at 24 weeks [Time Frame: week 24]

The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks [Time Frame: week 24]

The American College of Rheumatology 20/70 (ACR20/ACR70) response at 12 weeks [Time Frame: week 12]

The European League Against Rheumatism (EULAR) response at 12 weeks [Time Frame: week 12]

Secondary ID(s)

YISTAR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors