Long-term Observational Study to Evaluation the Safety of... | NCT04134169

Studies
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

NCT04134169

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Oct 10, 2022Actual

Enrollment

28Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not applicable(observational study)

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

Oct 2022

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

Oct 2, 2019Actual

Primary Completion Date

Aug 11, 2025Estimated

Completion Date

Apr 11, 2026Estimated

First Submitted Date

Oct 18, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 22, 2019Actual

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

Oct 7, 2022

Last Update Posted Date

Oct 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

Detailed Description

A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid arthritis			Other: Not applicable(observational study)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Not applicable(observational study)	Other	Not applicable(observational study)	Rheumatoid arthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Assessment	(Rate of Adverse Event, Number of Participants with Adverse Event)	5 years

Secondary Outcomes

Measure	Description	Time Frame
1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate		5 years
2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Any other condition which the investigator judges would make patient unsuitable for study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Moderate to Severe Rheumatoid arthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chae Eun Jeon	Contact	+82-2-20367614		cejeon@kangstem.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul national University Boramae medical center	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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