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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02404558
Eligibility Criteria:
Inclusion criteria:
* Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010
* Rheumatoid Arthritis Classification Criteria.
* ACR Class I-III functional status, based on the 1991 revised criteria.
Exclusion criteria:
* Patients less than 20 years of age.
* Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.
* Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
* Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
* Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.
* Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.
* Active or suspected tuberculosis (TB) or at high risk of contracting TB.
* Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02404558
Study Brief:
Protocol Section:
NCT02404558