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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT00781469
Eligibility Criteria:
Inclusion criteria
* Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
* Body weight greater \>40 kg and \<120 kg with a body mass index (BMI) between 19-31 kg/m2
* Clinical history of rheumatoid arthritis as defined by ACR criteria
* Negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
For populations B and C only
* Currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only DMARD (no changes in dosing regimen for 4 weeks prior to screening).
Exclusion criteria
* History of an acute illness within 2 weeks prior to the study
* History of drug abuse within 2 years
* Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication
For group A only
* Prior treatment with disease modifying anti-rheumatic agents or biologicals.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00781469
Study Brief:
Protocol Section:
NCT00781469