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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00425932
Eligibility Criteria:
Inclusion Criteria
* Able and willing to give written informed consent
* Age 18-80 years
* Must have active rheumatoid arthritis for at least 12 weeks, but no more than 5 years.
* Must be receiving treatment on an outpatient basis
* Must have \> 8 tender and swollen joints
* Must have negative serum pregnancy test
* Must have an inadequate response to MTX
* Must have elevated serology parameters
* Must have Positive RF or anti-CCP antibody, or radiographic evidence of at least one joint with definite erosion attributable to RA.
* Stable use of Corticosteroids is permitted
* Stable use of NSAIDs is permitted
Exclusion Criteria:
* History of or current inflammatory joint disease
* Functional class IV
* Any surgical procedure within 12 weeks
* Lack of peripheral venous access.
* Pregnancy or breast feeding.
* Significant cardiac or pulmonary disease.
* Evidence of significant uncontrolled concomitant disease
* Positive HIV
* Known active infection of any kind
* History of deep space/tissue infection
* History of recurrent significant infection
* Concomitant malignancies or previous malignancies
* Any neurological, vascular or systemic disorder
* History of drug, alcohol, or chemical abuse
* Inability to comply with study and follow-up procedures
* History of a severe allergic or anaphylactic reaction to a biologic agent
* Previous treatment with more than one biologic agent for RA. Patients must not have received a biologic agent within 2 months prior to the Baseline visit, except for etanercept, abatacept and anakinra for which a one month washout prior to Baseline visit is acceptable
* Previous treatment with an anti-alpha 4 integrin antibody or co-stimulation modulator.
* Previous treatment with any cell depleting therapies.
* Treatment with any investigational agent within 28 days
* Receipt of a live/attenuated vaccine within 28 days
* Ongoing use of high dose steroids (\>10mg/day)
* Inra-articular or parental glucocorticoids within 4 weeks prior to baseline.
* Intolerance or contraindications to i.v. glucocorticoids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00425932
Study Brief:
Protocol Section:
NCT00425932