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

October 7, 2022 updated by: Kang Stem Biotech Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
          • Sanghui Kim
          • Phone Number: +82-2-8703969

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

Moderate to Severe Rheumatoid arthritis

Description

Inclusion Criteria:

  1. Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
  2. 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

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
Rheumatoid arthritis
Other: Not applicable(observational study)
Not applicable(observational study)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
Time Frame: 5 years
5 years
2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
Time Frame: 5 years
5 years
change in DAS(Disease activity scores)28-ESR from baseline
Time Frame: 5 years
DAS range is from ≥ 3.2 (inactive) , >3.2 but ≤ 5.1(moderate), >5.1(very active)
5 years
change in KHAQ(Korean Health assessment questionnaire) from baseline
Time Frame: 5 years
KHAQ range is from 0 (clear) to 60 (severe)
5 years
change in CDAI (clinical disease activity index) from baseline
Time Frame: 5 years
CDAI range is from 0 (clear) to 76 (severe)
5 years
change in 100mm Pain VAS(Visual analogue scale) from baseline
Time Frame: 5 years
100mm Pain VAS range is from 0 (clear) to 100 (severe)
5 years
change in Modified Sharp/Van der Heijde Socre from baseline
Time Frame: 5 years
Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)
5 years

Collaborators and Investigators

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

Sponsor

Kang Stem Biotech Co., Ltd.

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)

October 2, 2019

Primary Completion (Anticipated)

August 11, 2025

Study Completion (Anticipated)

April 11, 2026

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K0202-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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