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

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Age 18-65 years with informed consent

• Fulfill the 2010 ACR/EULAR classification criteria for rheumatoid arthritis

• 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