Effectiveness and Safety of Tofacitinib in Korean Patient... | NCT03011281

Studies
Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

NCT03011281

Sponsor

Hanyang University

Status

Unknown status

Last Update Posted

Jun 25, 2020Actual

Enrollment

378Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Tofacitinib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Dec 30, 2016

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 5, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2020

Last Update Posted Date

Jun 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

To evaluate the baseline characteristics of Korean RA patients treated with Tofacitinib
To evaluate the effectiveness and safety of Tofacitinib in clinical practice in Korean RA patients.
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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

378Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tofacitinib	Drug		RA patients who start Tofacitinib	Xeljanz

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Assessment of efficacy with DAS28 (erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP))		5 years
Assessment of safety based on adverse events that occur during 5 years of patient monitoring.		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoon-Kyoung Sung, MD, PhD, MPH	Contact	82-2-2290-9250		sungyk@hanyang.ac.kr

Overall Officials

Name	Affiliation	Role
Yoon-Kyoung Sung, MD, PhD, MPH	Hanyang University Hospital for Rheumatic Diseases	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University	Recruiting	Seoul		04763	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C479163	tofacitinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided