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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT01120366
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with RA in accordance with the 1987 classification criteria of ACR
* Aged 20 to 75 years inclusive at enrolment (within 2 weeks before starting treatment with the investigational drug)
* Treated with MTX at ≥6 mg/week for at least 8 weeks immediately before enrolment
* Rheumatoid arthritis of duration ≤10 years
* DAS28-ESR ≥3.2 (within 2 weeks before starting treatment with the investigational drug)
* Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent
Major exclusion criteria:
* Patients who were Steinbrocker Class IV.
* Patients who received leflunomide within 12 weeks, DMARDs other than MTX within 8 weeks , or tacrolimus within 4 weeks before the 1st TCZ infusion.
* Patients who previously received biologic DMARDs including TCZ.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01120366
Study Brief:
Protocol Section:
NCT01120366