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

February 8, 2018 updated by: Kang Stem Biotech Co., Ltd.

Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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]

Study Type

Observational

Enrollment (Actual)

9

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Boramae Medical Center

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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
Non-Interventional Study
Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
Drug: FURESTEM-RA Inj.
Non-interventional observational study
Other Names:
  • Not applicable-observational study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Kang Stem Biotech Co., Ltd.

Investigators

  • Principal Investigator: Ki-chul Shin, SMG-SNU Boramae Medical Center

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)

June 29, 2016

Primary Completion (ACTUAL)

January 24, 2017

Study Completion (ANTICIPATED)

March 21, 2021

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSTBT_FURESTEM_RA_EXT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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