Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

June 23, 2020 updated by: Yoon-Kyoung Sung, Hanyang University

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RA patients who start 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.
Drug: Tofacitinib
Other Names:
  • Xeljanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Investigators

  • Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH, Hanyang University Hospital for Rheumatic Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUHRD-SPE-16-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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