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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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12 December 2020 |
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Main ID: |
NCT03508713 |
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Date of registration:
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04/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)
LELAND |
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Scientific title:
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Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China |
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Date of first enrolment:
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May 13, 2018 |
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Target sample size:
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200 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03508713 |
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Study type:
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Observational |
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Study design:
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Phase:
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Contacts
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Name:
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Min Yang, doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nanfang Hospital of Southern Medical University |
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Name:
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Min Yang, doctor |
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Address:
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Telephone:
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+86-13802911770 |
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Email:
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minyanggz@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- =18 years,
- be diagnosed with RA according to the 1987 or 2010 ACR criteria,
- in the course of the disease within 6 months,
- fill out questionnaires by oneself,
- fully understand the survey, agree to take part in the survey with signing the
informed consent, and authority the researchers to expose and use his or her personal
health information.
Exclusion Criteria:
- woman in pregnancy, lactation or plan to pregnant in the next 2 years,
- before enter this study, the patient joint any other RA clinical study in the past 24
weeks,
- according to the clinicians, one may not report his /or her life quality or the
utilization of leading medical resources.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: disease modified antirheumatic drugs or biological agents
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Primary Outcome(s)
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the proportion of patients achieving treat to target
[Time Frame: 2018-4-25 to 2022-7-1]
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Secondary Outcome(s)
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the change of European Quality of Life-5 Dimensions(EQ-5D)
[Time Frame: 2018-4-25 to 2022-7-1]
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the change of Short Form 36 Health Survey Questionnaire(SF-36)
[Time Frame: 2018-4-25 to 2022-7-1]
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the change of The Work Productivity and Activity Impairment Questionnaire(WPAI)
[Time Frame: 2018-4-25 to 2022-7-1]
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the change of Health Assessment Questionnaire Disability Index(HAQ-DI)
[Time Frame: 2018-4-25 to 2022-7-1]
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Secondary ID(s)
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LC2016PY020
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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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