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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03589833
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65 years with informed consent
* Diagnosis of rheumatoid arthritis (according to 2010 ACR/EULAR classification criteria)
* Disease duration \> 6 weeks
* Swollen joint (SJC)≥4 and tender joint count(TJC)≥4
* ESR \>28 mm/hr or C-reactive protein \> 1.5 ULN
* Positive RF or anti-CCP antibody on screening
* Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA
* No evidence of active or latent or inadequately treated Mycobacterium tuberculosis infection
Exclusion Criteria:
* Pregnant, lactating or further fertility requirements
* Previously received any biologic agents.
* Recently (\<12 weeks) received methotrexate, leflunomide, salazosulfapyridine, azathioprine, cyclosporine, mycophenolate mofetil or Tripterygium Wilfordii.
* Active or chronic infection, including HIV, HCV, HBV, tuberculosis.
* History of any other rheumatic autoimmune disease
* History of any lymphoproliferative disorder
* Malignancy or history of malignancy.
* Abnormal laboratory tests, including: Hemoglobin \<8.5 g/dL, White blood cell count \<3.5 x 109/L, Platelet count \<100 x 109/L, AST/ALT \>1.5 ULN, and serum creatine \> 1.5 mg/dL.
* Severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03589833
Study Brief:
Protocol Section:
NCT03589833