Condition category
Musculoskeletal Diseases
Date applied
28/04/2010
Date assigned
07/06/2010
Last edited
04/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

Overall trial start date

01/08/2010

Overall trial end date

31/07/2013

Reason abandoned

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21625887

Publication citations

Additional files

Editorial Notes

04/02/2016: Publication reference added