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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00605735
Eligibility Criteria:
Inclusion Criteria:
* Must have a diagnosis of RA for at least 6 months
* Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
* Must have at least 6 swollen and at least 8 tender joints
* CRP above upper limit of normal or ESR \> 28 mm/hr
* Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication
Exclusion Criteria:
* Any infection including TB, HIV, Hepatitis B or C
* Recent infection requiring antibiotics within 4 weeks
* History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
* Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00605735
Study Brief:
Protocol Section:
NCT00605735