Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Hanyang University378 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

378

Conditions

Rheumatoid Arthritis

Interventions

TofacitinibDRUG

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)

Time frame: 5 years

Secondary Outcomes

Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))

Time frame: 5 years

Assessment of safety based on adverse events that occur during 5 years of patient monitoring.

Time frame: 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.

Time frame: 5 years

Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)

Time frame: 5 years

Global Health assessment using Visual Analogue Scale (VAS)

Time frame: 5 years

Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)

Time frame: 5 years

Assessment of sleep disturbance using Visual Analogue Scale (VAS)

Time frame: 5 years

Assessment of efficacy with Simple Disease Activity Index (SDAI)

Time frame: 5 years

Assessment of efficacy with Clinical Disease Activity Index (CDAI)

Time frame: 5 years

Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria

Time frame: 5 years

Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)

Time frame: 5 years

Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts