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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT01559103
Eligibility Criteria:
Inclusion Criteria:
* Active Rheumatoid Arthritis (RA) for 6 months or more.
* Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
* Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
* Males, unless surgically sterile, must use 2 effective methods of birth control from Day 1 through follow-up.
Exclusion Criteria:
* History or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
* History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
* Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
* Current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
* Intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01559103
Study Brief:
Protocol Section:
NCT01559103