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

Phase 1TerminatedNCT02481180

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

T0001DRUG

injection (SC) T0001 15mg weekly for 12 weeks

T0001DRUG

injection (SC) T0001 30mg weekly for 12 weeks

T0001DRUG

injection (SC) T0001 30mg every two weeks for 12 weeks

T0001

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Maximum Tolerance Dose

Time frame: 4 weeks

Peak Plasma Concentration (Cmax)

Time frame: 14 weeks

Area under the plasma concentration versus time curve (AUC)

Time frame: 14 weeks

steady-state concentration（Css）

Time frame: 14 weeks

Secondary Outcomes

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)

Time frame: 12 weeks

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)

Time frame: 12 weeks

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)

Data from ClinicalTrials.gov

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