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

NCT02481180 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-07-08

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

T0001

injection (SC) T0001 15mg weekly for 12 weeks

DRUG

T0001

injection (SC) T0001 30mg weekly for 12 weeks

DRUG

T0001

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

DRUG

T0001

injection (SC) T0001 50mg every two weeks for 12 weeks

DRUG

Enbrel

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Li zhan Guo, Ph.D · Peking University People's Hospital

  • wang wei · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-11-06
Completion
2017-11-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481180 on ClinicalTrials.gov