Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

• Status: Terminated
• Trial end date: 2017-11-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of T0001 in Rheumatoid Arthritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
• Treatments: Etanercept; Immunoglobulin Fc Fragments; T0001

Criteria

Inclusion Criteria:

• Age 18-45 years old;

• Diagnosed with active RA;

• DMARDs therapy must not be used for at least 28 days prior to baseline;

• If a patient has received NSAIDs，current NSAIDs therapy must have been at a stable dose for at least 28 days prior to baseline;

• Patient or patient's legal representative able to give written informed consent for participation in the trial.

Exclusion Criteria:

• Acute or chronic infection, or history of active tuberculosis;

• History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;

• Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease);

• Patients who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);

• Patients who currently have, or who have a history of, malignancy;

• Patients who lack of understanding ,communication or collaboration, and can't comply with the protocols;

• Female patients who are breastfeeding or pregnant, who are of childbearing potential.