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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
T0001
T0001
T0001
T0001
Enbrel
Sponsored by
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T0001

Enbrel

Arm Description

Outcomes

Primary Outcome Measures

Maximum Tolerance Dose
Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)
steady-state concentration（Css）

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
June 18, 2015
Last Updated
July 5, 2019
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02481180
Brief Title
Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)
Official Title
An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance、Pharmacokinetics、Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Study Start Date
July 31, 2015 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T0001
Arm Type
Experimental
Arm Title
Enbrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
T0001
Intervention Description
injection (SC) T0001 15mg weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
T0001
Intervention Description
injection (SC) T0001 30mg weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
T0001
Intervention Description
injection (SC) T0001 30mg every two weeks for 12 weeks
Intervention Type
Drug
Intervention Name(s)
T0001
Intervention Description
injection (SC) T0001 50mg every two weeks for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Enbrel
Intervention Description
injection (SC) enbrel 50mg twice a week for 12 weeks
Primary Outcome Measure Information:
Title
Maximum Tolerance Dose
Time Frame
4 weeks
Title
Peak Plasma Concentration (Cmax)
Time Frame
14 weeks
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
14 weeks
Title
steady-state concentration（Css）
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
American College of Rheumatology 20% (ACR20) Response
Description
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
Title
American College of Rheumatology 50% (ACR50) Response
Description
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
Title
American College of Rheumatology 70% (ACR70) Response
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li zhan Guo, Ph.D
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
wang wei
Organizational Affiliation
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28542350
Citation
Shen Y, Li G, Gu C, Chen B, Chen A, Li H, Gao B, Liang C, Wu J, Yang T, Jin L, Su Y. T0001, a variant of TNFR2-Fc fusion protein, exhibits improved Fc effector functions through increased binding to membrane-bound TNFalpha. PLoS One. 2017 May 19;12(5):e0177891. doi: 10.1371/journal.pone.0177891. eCollection 2017.
Results Reference
derived

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

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