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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01007435
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ≥ 18 years of age.
* Rheumatoid arthritis of ≤ 2 years duration.
* Disease Activity Score 28 (DAS28) \> 3.2.
* Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
* Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative \> 1 erosion required at screening).
* Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
Exclusion Criteria:
* Previous treatment with tocilizumab.
* Previous treatment with methotrexate or biologic agent.
* Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
* History of or current inflammatory joint disease other than RA.
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01007435
Study Brief:
Protocol Section:
NCT01007435