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

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase

Terminated

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: T0001

Drug: Enbrel

Study type

Interventional

Funder types

Industry

Identifiers

T0001-P2.0

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.