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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT01741493
Eligibility Criteria:
Inclusion Criteria:
Healthy Volunteers:
* Male and female subjects 18 to 55 years of age, inclusive.
* Subject is judged to be in good general health.
Rheumatoid Arthritis Patients:
* Male and female patients 18 to 75 years of age, inclusive.
* Subject has a diagnosis of rheumatoid arthritis for at least six months.
* Subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks.
Exclusion Criteria:
* History or evidence of active or latent tuberculosis.
* History or significant allergic reaction to any drug.
* Use of known strong CYP3A and CYP2D6 inhibitors and CYP3A inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer.
* Current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy.
* History of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01741493
Study Brief:
Protocol Section:
NCT01741493