Clinical trial NCT02481180: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximum Tolerance Dose
timeFrame: 4 weeks
measure: Peak Plasma Concentration (Cmax)
timeFrame: 14 weeks
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 14 weeks
measure: steady-state concentration（Css）
timeFrame: 14 weeks
Secondary outcomes:
measure: American College of Rheumatology 20% (ACR20) Response
timeFrame: 12 weeks
measure: American College of Rheumatology 50% (ACR50) Response
timeFrame: 12 weeks
measure: American College of Rheumatology 70% (ACR70) Response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Li zhan Guo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
name: wang wei
role: STUDY_DIRECTOR
References:
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.