NCT03106259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2021

Completed
Last Updated

February 9, 2018

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

April 3, 2017

Last Update Submit

February 8, 2018

Conditions

Rheumatoid Arthritis

Keywords

FURESTEM-RA

Outcome Measures

Primary Outcomes (1)

  • Safety of FURESTEM-RA Inj.

    Evaluate the number of adverse events Safety of FURESTEM-RA Inj.

    5 years

Study Arms (1)

Non-Interventional Study

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

Drug: FURESTEM-RA Inj.

Interventions

FURESTEM-RA Inj.DRUG

Non-interventional observational study

Also known as: Not applicable-observational study
Non-Interventional Study

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national University Boramae medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ki-chul Shin

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 10, 2017

Study Start

June 29, 2016

Primary Completion

January 24, 2017

Study Completion

March 21, 2021

Last Updated

February 9, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)