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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Rheumatoid arthritis
Prof Jacob van Laar
+44 (0)1642 282498
See all trial contact details
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN82317088
Primary Trial ID Number
Summary
Not provided at time of registration
Research Details
  • B cell depletion with rituximab suppresses inflammation and bone turnover in rheumatoid arthritis
Phase
Not Specified
Study Design
Multicentre open label single treatment arm prospective clinical trial
Study Type
Interventional
Intervention

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.

Intervention Type
Drug
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.
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
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
Trial Location(s)
South Tees NHS Trust
Middlesbrough
Teeside
TS4 3BW
Trial Contact(s)
Primary Trial Contact
Prof Jacob van Laar
j.m.van-laar@stees.nhs.uk
+44 (0)1642 282498
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Roche UK (UK)
Other Study ID Numbers
v1.7 08Jun10
Sponsor(s)
South Tees Hospitals NHS Foundation Trust (UK)
Key Dates

Recruitment Start Date

01 Aug 2010

Recruitment End Date

31 Jul 2013

Trial Start Date

01 Aug 2010

Trial End Date

31 Jul 2013

Date Assigned

07 Jun 2010

Last Updated

08 Jun 2010