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ISRCTN
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ISRCTN98945627
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ClinicalTrials.gov identifier
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Public title
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Control of Rheumatoid Arthritis (RA) by oral tolerance
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Scientific title
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Acronym
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N/A
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Serial number at source
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S0523
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Study hypothesis
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Not provided at time of registration
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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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Rheumatoid arthritis
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Participants - inclusion criteria
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1. RA patients aged over 18 and fulfilling the 1987 American College of Rheumatology (ACR) criteria for the diagnosis of RA were entered into the study after giving their written informed consent
2. Patients must have had the disease at least two years and have failed at least one Slow Acting Anti-Rheumatic Drug (SAARD)
3. All the patients had to have active arthritis defined by the presence of three out of four clinical criteria: three or more swollen joints, six or more tender joints, early morning stiffness over 45 minutes and Erythrocyte Sedimentation Rate (ESR) over 28 mm/h. Oral steroid treatment was permitted if the dose was more than 10 mg/day
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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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01/01/1998
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Anticipated end date
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01/01/2000
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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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Not provided at time of registration
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Interventions
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Patients were randomly assigned to receive either 0.05 mg, 0.5 mg or 5 mg daily of bovine type II collagen (CII) or placebo for six months
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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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Arthritis Research Campaign (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11592359
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Contact name
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Dr
Ernest
Choy
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Address
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Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
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City/town
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London
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Zip/Postcode
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SE22 8PT
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Country
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United Kingdom
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Tel
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+44 (0)20 7346 6446
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Fax
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+44 (0)20 7346 6475
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Email
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ernest.choy@kcl.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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18/07/2002
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Last edited
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04/10/2007
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Date ISRCTN assigned
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18/07/2002
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