Clinical trial NCT03011281: Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
Official title: Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 378
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics

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.


Eligibility criteria: 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

Primary outcomes:
measure: DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
timeFrame: 5 years
Secondary outcomes:
measure: Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))
timeFrame: 5 years
measure: Assessment of safety based on adverse events that occur during 5 years of patient monitoring.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: 5 years
measure: Global Health assessment using Visual Analogue Scale (VAS)
timeFrame: 5 years
measure: Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)
timeFrame: 5 years
measure: Assessment of sleep disturbance using Visual Analogue Scale (VAS)
timeFrame: 5 years
measure: Assessment of efficacy with Simple Disease Activity Index (SDAI)
timeFrame: 5 years
measure: Assessment of efficacy with Clinical Disease Activity Index (CDAI)
timeFrame: 5 years
measure: Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria
timeFrame: 5 years
measure: Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
affiliation: Hanyang University Hospital for Rheumatic Diseases
name: Yoon-Kyoung Sung, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: