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View Clinical Trial (Medical Research Study)
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A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis - NCT00443651-53045 (Clinical Trial 164754)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy164754.aspx
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| City: |
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Brookfield |
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State:
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WI |
| Zip Code: |
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53045 |
| Conditions: |
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Rheumatoid Arthritis |
| Purpose: |
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This is a Phase III, open-label study of a total of approximately 560 subjects with active
RA who have had an inadequate response to one or more Disease-modifying antirheumatic drugs
(DMARDs). The study will be conducted in two stages. For Stage I of the study, approximately
400 subjects receiving non-biologic DMARDs (with the exception of MTX monotherapy or MTX and
leflunomide combination therapy) will be enrolled. In addition, during Stage II,
approximately 160 subjects receiving an FDA-approved biologic DMARD at the time of screening
will be enrolled.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria (Stage I):
- Male or female subjects, between 18 and 80 years of age, who have a documented
diagnosis of active RA for ≥ 6 months
- Receiving treatment for RA on an outpatient basis
- Have had an inadequate response to at least one non-biologic 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 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 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 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
- 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 |
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| Study is available at: |
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W Suburban Ctr for Arthritis
Brookfield, WI 53045
United States
Primary Contact:
Valerie Graff
Phone: 262-785-0777
Secondary Contact:
Farah Anwar
Email: anwar.farah@gene.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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