Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody | Not Recruiting
Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody
RituxRABone
Trial Source

Health Conditions
  • Rheumatoid arthritis
Not Recruiting
Recruitment Status
ISRCTN82317088
Primary Trial ID Number
Summary
B cell depletion with rituximab suppresses inflammation and bone turnover in rheumatoid arthritis
Primary Outcome Measures
  • Change in bone mineral density of spine, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months
Secondary Outcome Measures
  • 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.
Research Question
  • B cell depletion with rituximab suppresses inflammation and bone turnover in rheumatoid arthritis
Design Type
Sorry, this information is not available
Ethics Approval
Pending
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
46
Participant Inclusion Criteria
  • 1. Age 18 or older
  • 2. Established diagnosis of rheumatoid arthritis
  • 3. Eligible for treatment with rituximab
  • 4. Written informed consent
Participant Exclusion Criteria
  • 1. Concurrent bisphosphonate use
  • 2. Poor previous compliance
Interventions
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.
Design Details
Sorry, this information is not available
Study Design
Multicentre open label single treatment arm prospective clinical trial
Results Reporting
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Acronym
RituxRABone
Scientific Title
Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody: A multicentre, open-label, prospective clinical trial with single treatment arm
Secondary Trial Identifying Number
v1.7 08Jun10
Website
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Study Funded By
Roche UK (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
South Tees Hospitals NHS Foundation Trust (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Aug 2010

Recruitment End Date

31 Jul 2013

Trial End Date

31 Jul 2013

Date added to Registry

07 Jun 2010

Last Updated

08 Jun 2010