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ISRCTN
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ISRCTN65477168
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled study of combination therapy in rheumatoid arthritis (RA) patients with a suboptimal response to sulphasalazine
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Scientific title
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Acronym
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MASCOT
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Serial number at source
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C0640
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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. Male or female
2. Age 18 - 75 years
3. Onset of disease after age 16
4. Disease duration less than 5 years
5. Active inflammatory arthritis which is defined as six or more swollen joints plus two of the following:
5.1. Morning stiffness more than 45 minutes
5.2. Nine or more tender joints
5.3. Erythrocyte Sedimentation Rate (ESR) more than 28 mm/h
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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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31/07/2002
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Anticipated end date
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29/04/2005
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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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Sulphasalazine will be used as a disease modifying agent for 6 months, target dose 40 mg/kg (to maximum tolerated dose or 4 g daily as maximum permitted dose). At 6 months those with a suboptimal response defined below will be randomly allocated to:
1. Sulphasalazine and methotrexate placebo
2. Sulphasalazine and active methotrexate
3. Active methotrexate and sulphasalazine placebo
The maximum permitted dose of methotrexate will be 30 mg/week or methotrexate placebo. The maximum permitted dose of sulphasalazine will be 4 g/daily and no intra-articular or intramuscular steroid permitted within 1 month of the 6 month and 18 month assessments. All patients will receive weekly folic acid 5 mg daily between 6 and 18 months whether allocated to group 1, 2 or 3.
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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=16926184
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Contact name
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Dr
H
Capell
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Address
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Centre for Rheumatic Diseases
Glasgow Royal Infirmary
Castle Street
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City/town
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Glasgow
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Zip/Postcode
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G4 0SF
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Country
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United Kingdom
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Tel
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+44 (0)141 211 4965
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Email
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hilary.capell@northglasgow.scot.nhs.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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10/07/2002
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Last edited
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02/10/2007
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Date ISRCTN assigned
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10/07/2002
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