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
Secondary identifying numbers	HTA 94/45/02

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

ARC Epidemiology Research Unit
University of Manchester
Oxford Road
Stopford Building
Manchester
M13 9PT
United Kingdom

Phone	+44 (0)161 275 5044
Email	deborah@fs1.ser.man.ac.uk

Study information

Study design	Multi-centre observer-blinded controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/1997
Completion date	31/07/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

ARC Epidemiology Research Unit

Manchester
M13 9PT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (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	01/09/2005		Yes	No