NCT02481180

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 31, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2017

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

June 18, 2015

Last Update Submit

July 5, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • American College of Rheumatology 20% (ACR20) Response

    12 weeks

  • American College of Rheumatology 50% (ACR50) Response

    12 weeks

  • American College of Rheumatology 70% (ACR70) Response

    12 weeks

Study Arms (2)

T0001

EXPERIMENTAL
Drug: T0001

Enbrel

ACTIVE COMPARATOR
Drug: Enbrel

Interventions

T0001DRUG

injection (SC) T0001 15mg weekly for 12 weeks

T0001
EnbrelDRUG

injection (SC) enbrel 50mg twice a week for 12 weeks

Enbrel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

  • 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.

    PMID: 28542350DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

T0001Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Li zhan Guo, Ph.D

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

  • wang wei

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 25, 2015

Study Start

July 31, 2015

Primary Completion

November 6, 2017

Study Completion

November 6, 2017

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

CN(1)