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ISRCTN
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ISRCTN04058380
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ClinicalTrials.gov identifier
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Public title
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The British rheumatoid outcome study group (BROSG) trial of symptomatic versus aggressive therapy in established rheumatoid arthritis
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Scientific title
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Acronym
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BROSG
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Serial number at source
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HTA 94/45/02
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Multi-centre observer-blinded controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Rheumatoid arthritis
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Participants - inclusion criteria
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Patients with rheumatoid arthritis of 5-20 years duration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/05/1997
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Anticipated end date
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31/07/2002
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Status of trial
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Completed
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Patient information material
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Target number of participants
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480
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2005 Health Technology Assessment results on http://www.ncbi.nlm.nih.gov/pubmed/16153351
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Contact name
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Prof
Deborah
Symmons
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Address
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ARC Epidemiology Research Unit
University of Manchester
Oxford Road
Stopford Building
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City/town
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Manchester
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Zip/Postcode
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M13 9PT
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Country
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United Kingdom
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Tel
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+44 (0)161 275 5044
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Fax
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+44 (0)161 275 5043
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Email
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deborah@fs1.ser.man.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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14/07/2008
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Date ISRCTN assigned
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25/04/2003
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