The British rheumatoid outcome study group (BROSG) trial of symptomatic versus aggressive therapy in established rheumatoid arthritis
| ISRCTN | ISRCTN04058380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04058380 |
| Protocol serial number | HTA 94/45/02 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 24/08/2009
- 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 Deborah Symmons
Scientific
Scientific
ARC Epidemiology Research Unit
University of Manchester
Oxford Road
Stopford Building
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)161 275 5044 |
|---|---|
| deborah@fs1.ser.man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre observer-blinded controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | BROSG |
| Study objectives | This multi-centre observer-blinded controlled trial will compare the outcome, in terms of disability, of two groups of 240 RA patients with 5-20 years disease duration. Group 1 will be managed predominantly in primary care with the goal of controlling joint pain and stiffness. Group 2 will be predominantly in the rheumatology clinic with the goal of controlling symptoms and suppressing clinical laboratory evidence of inflammation. Only Group 2 will be eligible to receive cytotoxic drugs and parenteral steroids. Both groups will attend an annual review clinic to be screened for the complications of RA. Algorithms will guide physicians in their choice of drugs. The study will include assessment of direct and indirect costs. The multi-professional project team will include clinicians, an epidemiologist, statistician, computer scientist and a health economist. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Group 1 will be managed predominantly in primary care with the goal of controlling joint pain and stiffness. Group 2 will be predominantly in the rheumatology clinic with the goal of controlling symptoms and suppressing clinical laboratory evidence of inflammation. Only Group 2 will be eligible to receive cytotoxic drugs and parenteral steroids. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 480 |
| Key inclusion criteria | Patients with rheumatoid arthritis of 5-20 years duration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/1997 |
| Date of final enrolment | 31/07/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ARC Epidemiology Research Unit
Manchester
M13 9PT
United Kingdom
M13 9PT
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 | 01/09/2005 | Yes | No |
