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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01023256
Eligibility Criteria:
Inclusion Criteria:
* Rheumatoid arthritis (RA) per revised 1987 ACR criteria
* Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
* CRP \> 5.0 mg/L (RF and anti-CCP seronegative); CRP \>2 mg/l (RF and/or anti-CCP seropositive)
* DAS28 ≤ 5.1
* Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
* Negative PPD tuberculin skin test
Exclusion Criteria:
* Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
* Any history of ongoing, significant or recurring infections
* Any active inflammatory diseases other than RA
* Treatment with a systemic investigational drug within 6 months prior to screening
* Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
* Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
* Hepatic or renal insufficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01023256
Study Brief:
Protocol Section:
NCT01023256