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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134169
• Other study ID #: K0202-E
• Status: Recruiting
• Start date: October 2, 2019
• Est. completion date: April 11, 2026

Study information

• Verified date: October 2022
• Source: Kang Stem Biotech Co., Ltd.
• Contact: Chae Eun Jeon
• Phone: +82-2-20367614
• Email: cejeon[@]kangstem.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: April 11, 2026
• Est. primary completion date: August 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Not applicable(observational study)
Not applicable(observational study)

Locations

Country	Name	City	State
Korea, Republic of	Seoul national University Boramae medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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