Rheumatoid Arthritis Clinical Trial
Official title:
Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis
Verified date | August 2013 |
Source | Gaylis, Norman B., M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 evaluation of treatments.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Guillermo Valenzuela MD | Fort Lauderdale | Florida |
United States | Drs. Charles Kahn and Wayne Riskin | Hollywood | Florida |
United States | Arhtritis & Rheumatic Disease Specialties | Miami | Florida |
United States | McBride Clinic Orthopedic Center | Oklahoma City | Oklahoma |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
United States | Arthritis and Rheumatology Clinics of Kansas | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Gaylis, Norman B., M.D. | Genentech, Inc., Oklahoma Medical Research Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24. | 24 weeks | No | |
Secondary | Change from Baseline in 1.5 Tesla MRI synovitis score (RAMRIS system) at Week 12. | 12 weeks | No | |
Secondary | Change from Baseline in 1.5 Tesla MRI bone edema and total score (RAMRIS system) at Week 24. | 24 weeks | No | |
Secondary | Change from Baseline in 1.5 Tesla MRI bone edema, bone erosion and total score (RAMRIS system) at Week 12 and Week 48. | 12 and 48 weeks | No | |
Secondary | Proportion of patients at Week 48 without new bone erosions on 1.5 Tesla MRI. | 48 weeks | No | |
Secondary | Change from baseline in total Genant modified Sharp score on conventional radiographs at Week 24 and 48. | 24 and 48 weeks | No | |
Secondary | Change in Disease Activity Score (DAS 28) from Baseline to Week 24 and 48. | 24 and 48 weeks | No | |
Secondary | ACR remission and responder rates (20%, 50%, &)%) at Week 24 and 48. | 24 and 48 weeks | No | |
Secondary | Change from Baseline in functional assessments according to the HAQ scores at 24 and 48 Weeks. | 24 and 48 weeks | No | |
Secondary | Difference between relative results from conventional high-field strength 1.5 Tesla MRI and 0.2 Tesla dedicated extremity MRI in detection and grading of bone erosions, bone edema, and synovitis at Baseline and in Week 12,24, and 48 (C-scan validation). | 12, 24 and 48 weeks | No |
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