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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01679951
Eligibility Criteria:
Inclusion Criteria:
* Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening
* Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
* Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and Serum C reactive protein greater than or equal to 0.80 mg/dL at the time of screening
* Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening
Exclusion Criteria:
* Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy
* Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled
* Has ever received any approved or investigational biologic agent for a rheumatoid indication
* Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01679951
Study Brief:
Protocol Section:
NCT01679951