Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tofacitinib

• Registration Number: NCT03011281
• Lead Sponsor: Hanyang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 378

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients who start Tofacitinib	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.

Primary Outcome Measures

Name	Time	Method
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)	5 years

Secondary Outcome Measures

Name	Time	Method
Assessment of efficacy with Simple Disease Activity Index (SDAI)	5 years
Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))	5 years
Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)	5 years
Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria	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
Global Health assessment using Visual Analogue Scale (VAS)	5 years
Assessment of sleep disturbance 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 Clinical Disease Activity Index (CDAI)	5 years
Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)	5 years

Trial Locations

Locations (1)

Hanyang University; 🇰🇷 Seoul, Korea, Republic of