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ISRCTN
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ISRCTN69908361
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ClinicalTrials.gov identifier
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Public title
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Intramuscular depomedrone in very early inflammatory polyarthritis
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Scientific title
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Acronym
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STIVEA
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Serial number at source
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S0671
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Study hypothesis
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That treating patients with very early inflammatory polyarthritis (less than 10 weeks duration) with a three week course of IM steroid will prevent a substantial proportion of cases from evolving into rheumatoid arthritis.
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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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Randomised 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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Inflammatory polyarthritis
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Participants - inclusion criteria
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Patients aged 18 years or more with inflammatory polyarthritis with a duration of 4 - 10 weeks.
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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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01/06/2003
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Anticipated end date
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01/06/2006
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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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346
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Interventions
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Patients will be randomised to receive:
1. Either weekly injections of 80 mg depomedrone (methyl prednisolone) deep into the gluteal muscles for 3 weeks
2. Placebo
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Primary outcome measure(s)
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The need to start second-line drug therapy (e.g. methotrexate, sulphasalazine) by the 6 month assessment.
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Secondary outcome measure(s)
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1. Whether the patient has satisfied classification criteria for rheumatoid arthritis
2. The presence of radiological erosions in the hands or feet at 12 months
3. The change in physical disability and clinical diagnosis
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Sources of funding
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Arthritis Research Campaign (UK)
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Trial website
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Publications
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Contact name
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Professor
Deborah
Symmons
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Address
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ARC Epidemiology Unit
University of Manchester
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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 5037
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Fax
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+44 (0)161 275 5043
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Email
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deborah.symmons@fs1.ser.man.ac.uk
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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05/02/2002
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Last edited
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28/09/2007
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Date ISRCTN assigned
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05/02/2002
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