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ISRCTN
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ISRCTN78142229
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ClinicalTrials.gov identifier
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Public title
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Active management of Rheumatoid Arthritis (RA)
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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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N0237084064
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Study hypothesis
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The aim of this study is to assess whether the use of an integrated care pathway for the management of Rheumatoid Arthritis improves outcome. The care pathway attempts to optimise the treatment of RA incorporating all the features of current good practice. It sets out precise treatment decisions based on a validated disease activity score rather than decisions been made on an ad hoc basis by the staff reviewing the patient in out patients.
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Lay summary
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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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Musculoskeletal Diseases: Rheumatoid arthritis (RA)
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Participants - inclusion criteria
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Patients attending the Rheumatology service at St Helens & Knowsley NHS Hospitals with active RA, who are on no more than one disease-modifying anti-rheumatic drug (DMARD), will be invited to participate in the study. Inclusion criteria:
1. Patients with active inflammatory polyarthropathy
2. Age 18 or more
3. On no DMARDs or monotherapy
4. Informed Consent
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Participants - exclusion criteria
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1. Inflammatory disease due to psoriatic arthritis or other clear or suspected cause other than RA
2. Pregnancy at the time of enrolment or planned during the course of the next 3 years
3. On more than one DMARD at time of enrolment
4. Severe systemic disease or major co-morbidity
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Anticipated start date
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15/08/2000
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Anticipated end date
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14/08/2003
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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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100 subjects - 50 to each arm of the study
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Interventions
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Randomised to either the care pathway or conventional outpatient review before any changes to their DMARD therapy are made. The control group (50 subjects) will be the patients receiving standard rheumatological care.
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Primary outcome measure(s)
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1. Larsen radiological score at 1 year and 2 years
2. Health Assessment Questionnaire (HAQ) assessment at baseline and every 6 months
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Secondary outcome measure(s)
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1. Assessment of remission at 1 and 2 years
2. Number of DMARDs (disease-modifying anti-rheumatic drugs) and dosage at 1 and 2 years
3. Admissions to the ward with active RA during course of the study
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Sources of funding
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St Helens and Knowsley Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Christina
Estrach
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Address
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Specialist Registrar in Rheumatology
Rheumatology Unit
Whiston Hospital
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City/town
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Prescot
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Zip/Postcode
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L35 5DR
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Country
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United Kingdom
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Tel
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+44 (0)151 426 8270
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Fax
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+44 (0)151 426 8345
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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01/11/2011
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Date ISRCTN assigned
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30/09/2004
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