Long-term Observational Study to Evaluation the Safety of... | NCT03106259

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

NCT03106259

Sponsor

Kang Stem Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Feb 9, 2018Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

FURESTEM-RA Inj.

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2016Actual

Primary Completion Date

Jan 24, 2017Actual

Completion Date

Mar 21, 2021Estimated

First Submitted Date

Apr 3, 2017

First Submission Date that Met QC Criteria

Apr 6, 2017

First Posted Date

Apr 10, 2017Actual

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

Feb 8, 2018

Last Update Posted Date

Feb 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

Detailed Description

This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.

[NCT02221258]

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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Interventional Study		Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]	Drug: FURESTEM-RA Inj.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FURESTEM-RA Inj.	Drug	Non-interventional observational study	Non-Interventional Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of FURESTEM-RA Inj.	Evaluate the number of adverse events Safety of FURESTEM-RA Inj.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
Subject who understands and voluntarily sign an informed consent form

Exclusion Criteria:

In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period

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

Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. [NCT02221258]

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ki-chul Shin	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

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