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ISRCTN
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ISRCTN77249875
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ClinicalTrials.gov identifier
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Public title
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Objective assessment of the remission state and Predictors of sustained Remission in Rheumatoid Arthritis: leading to development of new management guidelines
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Scientific title
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Acronym
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OPRRA
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Serial number at source
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N/A
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Study hypothesis
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The presence of sustained clinical remission is dependant on objective imaging and immunological characteristics of remission.
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Ethics approval
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Approval received from the Harrogate Local Research Ethics Committee on th 21st September 2005 (ref: 05/Q1107/57).
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Study design
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Prospective observational study of two cohorts: early rheumatoid arthritis patients, and established rheumatoid arthritis patients
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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. Aged over 18 years
2. Male or female
3. American College of Rheumatology (ACR) diagnosis of rheumatoid arthritis
4. Stable Tumor Necrotising Factor (TNF) antagonist and concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) (e.g. methotrexate treatment for six months)
5. Clinical remission for six months (at time of screening) as defined by Disease Activity Score (DAS28) less than 2.6
6. No clinical indication to change current treatment
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Participants - exclusion criteria
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1. Patients who are unwilling or unable to give consent
2. Patients who are pregnant
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Anticipated start date
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01/12/2005
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Anticipated end date
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01/06/2008
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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
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Interventions
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1. Withdrawal of anti-TNF therapy
2. Ultrasound of hands of dominant hand
3. Metacarpophalangeal joints two to five and wrist
4. X-ray of hands and feet
5. Blood tests for immunological assessment
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Primary outcome measure(s)
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The number of patients experiencing flare of disease at six months (defined as an increase in DAS28 more than 1.2 or to a total DAS more than 2.6).
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Secondary outcome measure(s)
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1. Change in damage at six months when compared to baseline as measured by X-ray of both hands and feet (modified Sharpe Van de Heijde score) and ultrasound
2. Change in clinical and laboratory markers of disease activity, function and quality of life
3. Assessment of regulatory T cell levels in remission patients
4. Flare of disease by 12 months
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Sources of funding
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Abbott Laboratories Ltd (UK)
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Trial website
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Publications
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Contact name
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Prof
Paul
Emery
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Address
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c/o Dr Benazir Saleem
Academic Unit of Musculoskeletal Disease
2nd Floor, Chapel Allerton Hospital
Chapeltown Road
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City/town
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Leeds
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Zip/Postcode
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LS7 4SA
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Country
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United Kingdom
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Tel
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+44 (0)113 392 4883
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Email
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benazir_saleem@yahoo.co.uk
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Sponsor
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University of Leeds (UK)
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Address
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c/o Clare Skinner
Research Grants Manager
School of Medicine
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City/town
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Leeds
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Zip/Postcode
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LS2 9JT
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Country
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United Kingdom
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Tel
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+44 (0)113 3434897
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Email
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c.e.skinner@leeds.ac.uk
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Sponsor website:
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http://www.leeds.ac.uk/
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Date applied
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15/12/2006
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Last edited
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30/04/2007
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Date ISRCTN assigned
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30/04/2007
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