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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: |
NCT03011281 |
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Date of registration:
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30/12/2016 |
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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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Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
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Scientific title:
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Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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378 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03011281 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Yoon-Kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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82-2-2290-9250 |
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Email:
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sungyk@hanyang.ac.kr |
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Affiliation:
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Name:
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Yoon-kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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82-2-2290-9250 |
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Email:
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sungyk@hanyang.ac.kr |
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Affiliation:
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Name:
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Yoon-Kyoung Sung, MD, PhD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hanyang University Hospital for Rheumatic Diseases |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A. Patients who provide a written informed consent form of participating in this study.
B. Patients who are more than 19 years old. C. Patients with moderately to severely active
rheumatoid arthritis as defined per EULAR guidelines, who have had an inadequate response
or are intolerant to methotrexate.
Exclusion Criteria:
A. Patients who do not provide a written informed consent form of participating in this
study
Age minimum:
19 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: Tofacitinib
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Primary Outcome(s)
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DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
[Time Frame: 5 years]
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Secondary Outcome(s)
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Assessment of adherence with Patient-reported Adherence, and Medication Possession Ratio (MPR) at 24, 48, 72, 96, 120, 144, 168, 192, 216 and 240 weeks of clinical visit.
[Time Frame: 5 years]
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Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
[Time Frame: 5 years]
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Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
[Time Frame: 5 years]
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Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
[Time Frame: 5 years]
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Assessment of efficacy with Clinical Disease Activity Index (CDAI)
[Time Frame: 5 years]
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Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
[Time Frame: 5 years]
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Assessment of efficacy with Simple Disease Activity Index (SDAI)
[Time Frame: 5 years]
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Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
[Time Frame: 5 years]
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Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
[Time Frame: 5 years]
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Global Health assessment using Visual Analogue Scale (VAS)
[Time Frame: 5 years]
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Assessment of sleep disturbance using Visual Analogue Scale (VAS)
[Time Frame: 5 years]
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Secondary ID(s)
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HUHRD-SPE-16-09
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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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