Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively 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 Deborah Symmons

ORCID ID

Contact details

ARC Epidemiology Research Unit
University of Manchester
Oxford Road
Stopford Building
Manchester
M13 9PT
United Kingdom
+44 (0)161 275 5044
deborah@fs1.ser.man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 94/45/02

Study information

Scientific title

Acronym

BROSG

Study hypothesis

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

Not provided at time of registration

Study design

Multi-centre observer-blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/1997

Overall trial end date

31/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with rheumatoid arthritis of 5-20 years duration

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

480

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/05/1997

Recruitment end date

31/07/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ARC Epidemiology Research Unit
Manchester
M13 9PT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16153351

Publication citations

  1. Results

    Symmons D, Tricker K, Roberts C, Davies L, Dawes P, Scott DL, The British Rheumatoid Outcome Study Group (BROSG) randomised controlled trial to compare the effectiveness and cost-effectiveness of aggressive versus symptomatic therapy in established rheumatoid arthritis., Health Technol Assess, 2005, 9, 34, iii-iv, ix-x, 1-78.

Additional files

Editorial Notes