Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011281
• Other study ID #: HUHRD-SPE-16-09
• Status: Recruiting
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: Hanyang University
• Contact: Yoon-Kyoung Sung, MD, PhD, MPH
• Phone: 82-2-2290-9250
• Email: sungyk[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tofacitinib

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)		5 years
Secondary	Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))		5 years
Secondary	Assessment of safety based on adverse events that occur during 5 years of patient monitoring.		5 years
Secondary	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
Secondary	Assessment of Quality of life by European Quality of Life-5 Dimensions (EQ-5D)		5 years
Secondary	Global Health assessment using Visual Analogue Scale (VAS)		5 years
Secondary	Assessment of fatigue by Functional Assessment of Chronic Illness Therapy -Fatigue (FACIT-Fatigue)		5 years
Secondary	Assessment of sleep disturbance using Visual Analogue Scale (VAS)		5 years
Secondary	Assessment of efficacy with Simple Disease Activity Index (SDAI)		5 years
Secondary	Assessment of efficacy with Clinical Disease Activity Index (CDAI)		5 years
Secondary	Assessment of efficacy with European League Against Rheumatism (EULAR) response Criteria		5 years
Secondary	Assessment of Quality of life by Health Assessment Questionnaire Disability Index (HAQ-DI)		5 years