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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance、Pharmacokinetics、Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02481180
• Other study ID #: T0001-P2.0
• Status: Terminated
• Phase: Phase 1
• Start date: July 31, 2015
• Est. completion date: November 6, 2017

Study information

• Verified date: July 2019
• Source: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: November 6, 2017
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• T0001
injection (SC) T0001 15mg weekly for 12 weeks
• T0001
injection (SC) T0001 30mg weekly for 12 weeks
• T0001
injection (SC) T0001 30mg every two weeks for 12 weeks
• T0001
injection (SC) T0001 50mg every two weeks for 12 weeks
• Enbrel
injection (SC) enbrel 50mg twice a week for 12 weeks

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerance Dose		4 weeks
Primary	Peak Plasma Concentration (Cmax)		14 weeks
Primary	Area under the plasma concentration versus time curve (AUC)		14 weeks
Primary	steady-state concentration(Css)		14 weeks
Secondary	American College of Rheumatology 20% (ACR20) Response	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)	12 weeks
Secondary	American College of Rheumatology 50% (ACR50) Response	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)	12 weeks
Secondary	American College of Rheumatology 70% (ACR70) Response	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)	12 weeks