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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01853033
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Rheumatoid Arthritis (RA) \> 3 months.
* On methotrexate (MTX) therapy =\> 3 months and on a stable dose for at least 4 weeks.
* Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.
* Body Mass Index (BMI) is 19 to 38, inclusive.
* Other than RA, subjects should be in good general health.
Exclusion Criteria:
* Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.
* History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.
* History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.
* History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.
* Subject has any medical condition or illness other than RA that is not well controlled with treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01853033
Study Brief:
Protocol Section:
NCT01853033