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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT01742468
Eligibility Criteria:
Inclusion Criteria:
* Patient has a diagnosis of RA (according to the ACR classification criteria, revised 2010) for at least 6 months prior to randomization.
* Patient has a moderate disease activity as defined by disease activity score DAS28 ≥ 2.4
* Patient has the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
* stable dosis of disease-modifying antirheumatic drugs within 4 weeks prior to randomization and presumably over the study periods (30 weeks).
Exclusion Criteria:
* Intra-articular corticosteroids within 4 weeks prior to randomization or blood sample taking
* Patients are permitted to receive either oral or parenteral glucocorticoids equivalent to ≤10 mg daily prednisone and nonsteroidal anti-inflammatory drug, if they have received a stable dose for at least 4 weeks prior to randomization and presumably over the study periods (30 weeks).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01742468
Study Brief:
Protocol Section:
NCT01742468