Rheumatoid Arthritis
Conditions
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. 1. To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib 2. To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients. 3. 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.
Interventions
DRUGTofacitinib
Sponsors
Hanyang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)) | 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 |
| Assessment of sleep disturbance using Visual Analogue Scale (VAS) | 5 years |
Countries
South Korea
Contacts
Primary ContactYoon-Kyoung Sung, MD, PhD, MPH
Outcome results
None listed