Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting antibody

ISRCTN	ISRCTN82317088
DOI	https://doi.org/10.1186/ISRCTN82317088
Secondary identifying numbers	v1.7 08Jun10

Submission date: 28/04/2010
Registration date: 07/06/2010
Last edited: 04/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jacob van Laar
Scientific

South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital
Dept of Rheumatology
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 282498
Email	j.m.van-laar@stees.nhs.uk

Study information

Study design	Multicentre open label single treatment arm prospective clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	RituxRABone
Study objectives	B cell depletion with rituximab suppresses inflammation and bone turnover in rheumatoid arthritis
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/08/2010
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	46
Key inclusion criteria	1. Age 18 or older 2. Established diagnosis of rheumatoid arthritis 3. Eligible for treatment with rituximab 4. Written informed consent
Key exclusion criteria	1. Concurrent bisphosphonate use 2. Poor previous compliance
Date of first enrolment	01/08/2010
Date of final enrolment	31/07/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Tees Hospitals NHS Foundation Trust

Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

South Tees Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

The James Cook University Hospital
The Academic Division, The Academic Centre
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom

Phone	+44 (0)1642 854965
Email	julie.rowbotham@stees.nhs.uk
"ROR"	https://ror.org/02js17r36

Funders

Funder type

Industry

Roche (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No

Editorial Notes

04/02/2016: Publication reference added