Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
The objectives of this single center, prospective, non-interventional inception cohort is to understand patient characteristics, general treatment patterns, effectiveness, and safety of Tofacitinib for rheumatoid arthritis patients in the real-world setting.
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To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
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To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
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To further evaluate safety, effectiveness and demographic characteristics of the patients treated with Tofacitinib matched with and compared to biologic DMARDs from the BIOPSY registry database.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RA patients who start Tofacitinib Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics. |
Drug: Tofacitinib
Other Names:
|
Outcome Measures
Primary Outcome Measures
- DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%) [5 years]
Secondary Outcome Measures
- Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)) [5 years]
- Assessment of safety based on adverse events that occur during 5 years of patient monitoring. [5 years]
- 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. [5 years]
- Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D) [5 years]
- Global Health assessment using Visual Analogue Scale (VAS) [5 years]
- Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue) [5 years]
- Assessment of sleep disturbance using Visual Analogue Scale (VAS) [5 years]
- Assessment of efficacy with Simple Disease Activity Index (SDAI) [5 years]
- Assessment of efficacy with Clinical Disease Activity Index (CDAI) [5 years]
- Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria [5 years]
- Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI) [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who provide a written informed consent form of participating in this study.
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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:
- Patients who do not provide a written informed consent form of participating in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hanyang University | Seoul | Korea, Republic of | 04763 |
Sponsors and Collaborators
- Hanyang University
Investigators
- Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH, Hanyang University Hospital for Rheumatic Diseases
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUHRD-SPE-16-09