NCT04134169

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 2, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2026

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

October 18, 2019

Last Update Submit

October 7, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety Assessment

    (Rate of Adverse Event, Number of Participants with Adverse Event)

    5 years

Secondary Outcomes (7)

  • 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

  • change in DAS(Disease activity scores)28-ESR from baseline

    5 years

  • change in KHAQ(Korean Health assessment questionnaire) from baseline

    5 years

  • change in CDAI (clinical disease activity index) from baseline

    5 years

  • +2 more secondary outcomes

Study Arms (1)

Rheumatoid arthritis

Other: Not applicable(observational study)

Interventions

Not applicable(observational study)OTHER

Not applicable(observational study)

Rheumatoid arthritis

Eligibility Criteria

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

Moderate to Severe Rheumatoid arthritis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national University Boramae medical center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Chae Eun Jeon

CONTACT

+82-2-20367614cejeon@kangstem.com

Study Design

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

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

October 2, 2019

Primary Completion

August 11, 2025

Study Completion

April 11, 2026

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations

KR(1)