Contact information
Type
Scientific
Primary contact
Prof Jacob van Laar
ORCID ID
Contact details
South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital
Dept of Rheumatology
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 282498
j.m.van-laar@stees.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1.7 08Jun10
Study information
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
Acronym
RituxRABone
Study hypothesis
B cell depletion with rituximab suppresses inflammation and bone turnover in rheumatoid arthritis
Ethics approval
Ethics Committees of Leiden and Utrecht University Medical Centres in the Netherlands and the Research and Development department at The James Cook University Hospital, UK.
Study design
Multicentre open label single treatment arm prospective clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Rheumatoid arthritis
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
Phase
Not Specified
Drug names
Rituximab, methylprednisolone
Primary outcome measure
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.
Overall trial start date
01/08/2010
Overall trial end date
31/07/2013
Reason abandoned (if study stopped)
Eligibility
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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
46
Participant exclusion criteria
1. Concurrent bisphosphonate use
2. Poor previous compliance
Recruitment start date
01/08/2010
Recruitment end date
31/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Tees Hospitals NHS Foundation Trust
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
South Tees Hospitals NHS Foundation Trust (UK)
Sponsor details
The James Cook University Hospital
The Academic Division
The Academic Centre
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854965
julie.rowbotham@stees.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Roche (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21625887