Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Hanyang University

Status: Unknown

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib

Study type: Observational

Funder types: Other

Identifiers

NCT03011281

HUHRD-SPE-16-09

Details and patient eligibility

About

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.

Enrollment: 378 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

378 participants in 1 patient group

RA patients who start Tofacitinib

Description:

Korean RA patients who start Tofacitinib with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate or biologics.

Treatment:

Drug: Tofacitinib