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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00458861
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
* Methotrexate (10 mg/week to 25 mg/week) \> 3 months prior to Day 0 (stable dose \> 4 weeks prior to Day 0)
* Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy
Key Exclusion Criteria:
Medical History
* Serious local infection or systemic infection within 3 months of Day 0
* History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
Laboratory Tests
* Clinically significant lab tests at screening; or
* Positive for hepatitis C antibody or hepatitis B at screening
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00458861
Study Brief:
Protocol Section:
NCT00458861