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Health Condition(s) or Problem
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Rheumatoid arthritis
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Lay Summary
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Sorry, not currently available
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Who can enter the trial
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1. Age 18 or older
2. Established diagnosis of rheumatoid arthritis
3. Eligible for treatment with rituximab
4. Written informed consent
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Who cannot enter the trial
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1. Concurrent bisphosphonate use
2. Poor previous compliance
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What will happen
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This is a single treatment arm study involving 2 intravenous infusions of rituximab (1,000 mg/infusion) and methylprednisolone (100 mg/infusion), two weeks apart, as licensed for rheumatoid arthritis. Retreatment will be given if patients do not have low disease activity at 6 months according to standard practice. The duration of follow up is one year following the first infusion.
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Primary aim
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Change in bone mineral density of spine, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months
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Secondary Aim
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1. Changes in bone mineral density of hips and forearms, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months
2. Changes in biochemical markers of bone turnover
3. Changes in biomarkers of inflammation and autoreactivity
4. Changes in disease activity
5. Number of new fractures
6. Duration of B cell depletion in blood
All other outcomes (2-6) will be measured at baseline, 3, 6, 9, and 12 months using the following tools: Disease Activity Score for 28 Joints (DAS28), a validated and routine clinical assessment; Health Assessment Questionnaire (HAQ) a questionnaire-based investigation; Biomarkers are measured by a range of techniques incl flowcytometry, ELISA.
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Participant Information Sheet
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Not available in web format, please use contact details below to request a patient information sheet
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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Middlesbrough
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