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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT00443651
Eligibility Criteria:
Inclusion Criteria (Stage I):
* Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active rheumatoid arthritis (RA) for ≥ 6 months
* Receiving treatment for RA on an outpatient basis
* Have had an inadequate response to at least one non-biological disease-modifying anti-rheumatic drug (DMARD) and have been receiving this DMARD(s) for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline
* Demonstrated tolerability to currently prescribed DMARDs
* If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to the first day of treatment with rituximab (Day 1)
* Use of one nonsteroidal anti-inflammatory drug (NSAID) is permitted if the dose is stable for ≥ 2 weeks prior to Day 1
Exclusion Criteria (Stage I):
* Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)
* Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
* History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
* Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years
* Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of enrollment
* Lack of peripheral venous access
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
* Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation
* Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline
* History of medically significant opportunistic infection
* History of serious recurrent or chronic infection
* History of deep space/tissue infection within 52 weeks prior to baseline
* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
* History of significant cytopenias or other bone marrow disorders
* History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline
* Pregnancy or lactation
* Neuropathies and neurovasculopathies that might interfere with pain evaluation
* Methotrexate (MTX) monotherapy at the time of screening
* Concurrent treatment with MTX and leflunomide in combination
* Concurrent treatment with any biologic agent
* Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol
* History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins
* Previous treatment with an anti-α4 integrin agent
* Previous treatment with any cell-depleting therapies, including investigational agents
* Receipt of any vaccine within 28 days prior to baseline
* Intolerance or contraindications to IV corticosteroids
* Receipt of IV immunoglobulin (IVIG) or Prosorba\<TM\> column within 6 months prior to baseline
* Any previous treatment with rituximab
* Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
Inclusion Criteria (Stage II):
* Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active RA for ≥ 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA
* Receiving treatment for RA on an outpatient basis
* Have had an inadequate response to at least one biologic DMARD and have been receiving this agent at screening and for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline
* Have demonstrated tolerability to currently prescribed DMARDs/biologics
* If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to baseline
* Use of one NSAID is permitted if the dose is stable for ≥ 2 weeks prior to baseline
Exclusion Criteria (Stage II):
* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)
* Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
* History of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
* Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years
* Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of randomization
* Lack of peripheral venous access
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
* Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation
* Primary or secondary immunodeficiency (history of or currently active), including known history of HIV infection
* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline
* History of medically significant opportunistic infection
* History of serious recurrent or chronic infection
* History of deep space/tissue infection within 52 weeks prior to baseline
* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
* History of significant cytopenias or other bone marrow disorders
* History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline
* Pregnancy or lactation
* Neuropathies and neurovasculopathies that might interfere with pain evaluation
* Infliximab monotherapy at the time of screening (infliximab should be in combination with MTX)
* Concurrent treatment with MTX and leflunomide in combination
* Concurrent treatment with more than one biologic agent
* Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol
* History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins
* Previous treatment with an anti-α4 integrin agent
* Previous treatment with any cell-depleting therapies
* Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (whichever is the longer)
* Receipt of any vaccine within 28 days prior to baseline
* Intolerance or contraindications to IV corticosteroids
* Receipt of IVIG or Prosorba\<TM\> column within 6 months prior to baseline
* Any previous treatment with rituximab
* Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
* Positive purified protein derivative (PPD) skin test not adequately treated according to Center for Disease Control (CDC) guidelines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00443651
Study Brief:
Protocol Section:
NCT00443651