Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)
NCT ID: NCT02481180
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
36 participants
INTERVENTIONAL
2015-07-31
2017-11-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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T0001
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
Enbrel
injection (SC) enbrel 50mg twice a week for 12 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li zhan Guo, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
wang wei
Role: STUDY_DIRECTOR
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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.
Other Identifiers
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T0001-P2.0
Identifier Type: -
Identifier Source: org_study_id
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