Status:
COMPLETED
Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis
Lead Sponsor:
Gaylis, Norman B., M.D.
Collaborating Sponsors:
Oklahoma Medical Research Foundation
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to further investigate rituximab in the treatment of rheumatoid arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to improve the eval...
Detailed Description
Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin's B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis (RA) by the Food and ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00425932
Start Date
February 1 2007
End Date
November 1 2012
Last Update
August 22 2013
Active Locations (6)
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1
Guillermo Valenzuela MD
Fort Lauderdale, Florida, United States, 33324
2
Drs. Charles Kahn and Wayne Riskin
Hollywood, Florida, United States, 33021
3
Arhtritis & Rheumatic Disease Specialties
Miami, Florida, United States, 33180
4
Arthritis and Rheumatology Clinics of Kansas
Wichita, Kansas, United States, 67220