Status:
UNKNOWN
A Study of TJ003234 in Rheumatoid Arthritis Patients
Lead Sponsor:
I-Mab Biopharma US Limited
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Study Purpose and Design: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending D...
Eligibility Criteria
Inclusion
- Subjects must be ≥ 18 and ≤70 years old when signing the informed consent, with no limitation of gender.
- 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
- Employees of the hospital or any other person that paticipant in the study and their immedidte family members.
- 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.
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04457856
Start Date
August 6 2020
End Date
March 1 2023
Last Update
August 3 2022
Active Locations (5)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
2
Peking university people's Hospital
Beijing, Beijing Municipality, China, 10044
3
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
4
Zhongda Hospital southeast university
Nanjing, Jiangsu, China