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 |
| Protocol serial number | v1.7 08Jun10 |
| Sponsor | South Tees Hospitals NHS Foundation Trust (UK) |
| Funder | Roche (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| j.m.van-laar@stees.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre open label single treatment arm prospective clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rituximab, methylprednisolone |
| Primary outcome measure(s) |
Change in bone mineral density of spine, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months |
| Key secondary outcome measure(s) |
1. Changes in bone mineral density of hips and forearms, measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline and 12 months |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/02/2016: Publication reference added
