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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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23 May 2016 |
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Main ID: |
NCT02339441 |
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Date of registration:
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22/12/2014 |
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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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Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
ESOS |
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Scientific title:
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Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02339441 |
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Study type:
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Observational |
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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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Contacts
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Name:
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Ariane Herrick, MD, phD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manchester |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Age > 18 Skin thickening < 3 years Immunosuppressant use < 4 months Proximal skin
involvement to face/neck, elbow or knee
Exclusion Criteria:
Previous use of more than 4 months of methotrexate, mycophenolate mofetil,
cyclophosphamide or other immunosuppressive treatments
Previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil
or cyclophosphamide within previous months
Previous stem cell transplantation therapy
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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Early Diffuse Cutaneous Systemic Sclerosis
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Intervention(s)
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Drug: Mycophenolate mofetil
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Drug: Cyclophosphamide
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Drug: Methotrexate
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Primary Outcome(s)
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Skin score as measured by modified rodnan skin score
[Time Frame: 24 months]
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Secondary Outcome(s)
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Haemoglobin
[Time Frame: 24 months]
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Echocardiographic findings
[Time Frame: 24 months]
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Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale
[Time Frame: 24 months]
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Short form 36 questionnaire (SF-36)
[Time Frame: 24 months]
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Cochin hand function
[Time Frame: 24 months]
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Erythrocyte sedimentation rate
[Time Frame: 24 months]
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Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP)
[Time Frame: 24 months]
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Scleroderma Health Assessment Questionnaire
[Time Frame: 24 months]
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Estimated glomerular filtration rate (eGFR)
[Time Frame: 24 months]
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Secondary ID(s)
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10H101429
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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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