Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04457856
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04457856
Study Brief:
Protocol Section:
NCT04457856