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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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01813617 |
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Date of registration:
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13/03/2013 |
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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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Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis
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Scientific title:
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Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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72 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01813617 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Helene Alexanderson, PhD, RPT |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska University Hospital / Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Probable or definite polymyositis and dermatomyositis
- Performed both the FI-2 and the MMT at time of diagnosis
Exclusion Criteria:
- Patients with diagnosis inclusions body myositis
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dermatomyositis
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Polymyositis
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Intervention(s)
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Drug: Immunosuppressive Agents
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Primary Outcome(s)
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Functional Index 2 assessing change in muscle function over time.
[Time Frame: 0, 6 and 12 months]
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Secondary Outcome(s)
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Manual Muscle test, MMT-8, assessing change in muscle function over time.
[Time Frame: 0, 6 and 12 months]
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Secondary ID(s)
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Centre of Care Science
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SweMyoNet 1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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