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 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT02115750
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults
* RA (Rheumatoid Arthritis) diagnosis for 6 months
* On stable dose of MTX of 8mg to 25mg per week
* Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2
Exclusion Criteria:
* Use of prednisone greater than 10mg/day
* Use of greater than one non-steroidal anti-inflammatory drug (NSAID)
* Use of biologic therapies for any cause
* Chemistry and hematology values outside protocol specified range
* Positive QuantiFERON-tuberculosis (TB) Gold Test
* Evidence of active lung disease on chest x-ray
* Major systemic infections
* Presence of significant comorbid conditions
* Known allergy to latex
* Women who are pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02115750
Study Brief:
Protocol Section:
NCT02115750