Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to assess the MTD, Pharmacokinetics and preliminary efficacy of T0001 in Rheumatoid Arthritis.
Interventions
DRUGT0001
injection (SC) T0001 15mg weekly for 12 weeks
DRUGEnbrel
injection (SC) enbrel 50mg twice a week for 12 weeks
Sponsors
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerance Dose | 4 weeks |
| Peak Plasma Concentration (Cmax) | 14 weeks |
| Area under the plasma concentration versus time curve (AUC) | 14 weeks |
| steady-state concentration（Css） | 14 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology 50% (ACR50) Response | 12 weeks | ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS) |
| American College of Rheumatology 70% (ACR70) Response | 12 weeks | ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS) |
| American College of Rheumatology 20% (ACR20) Response | 12 weeks | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS) |
Countries
China
Outcome results
None listed