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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201208000399382 |
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Date of registration:
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23/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ORBIT study
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Scientific title:
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Outcomes in Rheumatoid arthritis By Intense Treatment |
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Date of first enrolment:
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04/04/2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=399 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using a radomisation table created by a computer software program,Concealment by sealed envelope
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Phase:
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Phase-0
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Mohammed
Tikly |
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Address:
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Chris Hani Baragwanath Academic Hospital
2014
Johannesburg
South Africa |
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Telephone:
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+27 (0)11 933 9377 |
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Email:
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tiklymohammed01@gmail.com |
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Affiliation:
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Head of Department |
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Name:
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Nthabiseng
Monyai |
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Address:
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Chris Hanagwanath academic Hospitali Bar
2014
Johannesburg
South Africa |
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Telephone:
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+27 (0)11 933 9377 |
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Email:
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nthabi.monyai@gmail.com |
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Affiliation:
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study co-ordinator |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) meet the 2011 revised American College of Rheumatology/EULAR classification criteria for RA
2) >18 years of age
3) naive to DMARD therapy at baseline
4) informed consent
Exclusion criteria: Patients with contra-indication to methotrexate or corticosteroid therapy will be excluded (eg patients with Hepatitis B or C, HIV positive, pregnant or lactating or planning pregnancy within the next 12 months, uncontrolled diabetes mellitus)
Age minimum:
18 Year(s)
Age maximum:
95 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Rheumatoid Arthritis
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Intervention(s)
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CDAI
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SDAI
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Primary Outcome(s)
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To compare the clinical utility of the CDAI versus the SDAI in an intense outpatient management strategy in patients with early rheumatoid arthritis
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Secondary Outcome(s)
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To assess the outcomes of the two groups in terms of functional disability and health-related quality of life
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Source(s) of Monetary Support
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Connective Tissue Diseases Research Fund University of the Witwatersrand
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Ethics review
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Status: Approved
Approval date: 21/04/2011
Contact:
Human Research Ethics Committee (Medical) UNIVERSITY OF THE WITWATERSRAND
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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