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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT01251120
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, over the age of 18 years
* Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2 years duration
* DAS28 \>3.2
* Swollen joint count (SJC) \>/=6 (66 joint count), and tender joint count (TJC) \>/=6 (68 joint count)
* Patients who have received DMARDs (including methotrexate) for 3-7 months
Exclusion Criteria:
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens syndrome or nodulosis with RA is permitted)
* Functional class III or IV as defined by ACR Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01251120
Study Brief:
Protocol Section:
NCT01251120