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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UNKNOWN
PHASE1
63 participants
INTERVENTIONAL
2020-08-06
2023-03-31
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
SINGLE
Study Groups
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TJ003234
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion
TJ003234 injection
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
Placebo
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks) Mode of administration: The investigational drug is administered by intravenous infusion
TJ003234 injection
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
Interventions
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TJ003234 injection
Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
Eligibility Criteria
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Inclusion Criteria
* Established Rheumatoid arthritis patients, diagnosed by ACR/EULAR criteria 2010 at least 6 months prior to randomisation.
* Single Ascending Dose: DAS28 score≤3.2. Multiple Ascending Dose: DAS28 score≤5.1 and \>3.2.
* Allowed one or more standard treatments, but the start date should no later than 12 weeks(84 days) before the randomisation and should take at a stable dose more than 4 weeks(28 days) before the randomisation. The combination taken of Methotrexate (MTX) and leflunomide was not allowed within 4 weeks (28 days) before randomization.
* Subjects must agree to attendance the study and signed the inform concent by themselves.
* Subjects(include subjects's wife) are no pregnancy plan during the sceering and 3 months after complete the study and agree to use contraceptives that protocol suggest.
Exclusion Criteria
* A documented history of an autoimmune disease other than RA (other than secondary Sjögren's syndrome) .
* Previous received Any biologic DMARD therapy including tsDMARD. •A positive hepatitis B (HBsAg, anti-HBc, and/or IgM anti-HBc), hepatitis C or HIV test at screening, indicative of a current or past infection.
* A history of active tuberculosis (TB) or positive serological test for TB (Quantiferon TB Gold or T-SPOT).
* Female patients who are pregnant during the study, or are breastfeeding. •Malignancy, or prior malignancy, with a disease free interval of \<5 years after diagnosis and intervention except curative treatment for basal and squamous cell skin cancer.
18 Years
70 Years
ALL
No
Sponsors
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I-Mab Biopharma US Limited
INDUSTRY
Responsible Party
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Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Peking university people's Hospital
Beijing, Beijing Municipality, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital southeast university
Nanjing, Jiangsu, China
FuDan University shanghai huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TJ003234RAR102
Identifier Type: -
Identifier Source: org_study_id
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