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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT01567358
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg\~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit
Exclusion Criteria:
1. History of following diseases
* Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
* Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
* Severe infectious disease（hepatitis, pneumonia、sepsis）
* History of demyelinating disease or multiple sclerosis
* Congestive heart failure
* lymphoproliferative disorder or myelodysplastic syndrome
* History of malignancy
* Interstitial lung disease
2. Patients with active or latent tuberculosis or history of tuberculosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01567358
Study Brief:
Protocol Section:
NCT01567358