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

Phase 1

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: T0001; Drug: Enbrel

• Registration Number: NCT02481180
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Study Start: 2015-07-31
• Primary Completion: 2017-11-06
• Study Completion: 2017-11-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T0001	T0001	-
Enbrel	Enbrel	-

Primary Outcome Measures

Name	Time	Method
steady-state concentration（Css）	14 weeks
Peak Plasma Concentration (Cmax)	14 weeks
Area under the plasma concentration versus time curve (AUC)	14 weeks
Maximum Tolerance Dose	4 weeks

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China