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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
DAS28-ESR (erythrocyte sedimentation rate) remission (DAS28 < 2.6) rate (%)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanyang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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