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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00639834
Eligibility Criteria:
Inclusion Criteria:
* Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
* Must have active RA
* Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
* All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration
Exclusion Criteria:
* Both Rheumatoid factor and anti-CCP negative
* Prior treatment with any B-cell depleting therapy
* Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
* History of or current inflammatory joint disease other than RA
* Neuropathies or neurovasculopathies that might interfere with pain evaluation
* Complications of RA or other disease
* Any other autoimmune disease other than RA
* Acute or chronic infection
* Clinically significant disease requiring
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00639834
Study Brief:
Protocol Section:
NCT00639834