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

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Not applicable(observational study)

• Registration Number: NCT04134169
• Lead Sponsor: Kang Stem Biotech Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2019-10-02
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10
• Primary Completion: 2025-08-11
• Study Completion: 2026-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis	Not applicable(observational study)	-

Primary Outcome Measures

Name	Time	Method
Safety Assessment	5 years	(Rate of Adverse Event, Number of Participants with Adverse Event)

Secondary Outcome Measures

Name	Time	Method
change in DAS(Disease activity scores)28-ESR from baseline	5 years	DAS range is from ≥ 3.2 (inactive) , \>3.2 but ≤ 5.1(moderate), \>5.1(very active)
change in CDAI (clinical disease activity index) from baseline	5 years	CDAI range is from 0 (clear) to 76 (severe)
change in KHAQ(Korean Health assessment questionnaire) from baseline	5 years	KHAQ range is from 0 (clear) to 60 (severe)
change in Modified Sharp/Van der Heijde Socre from baseline	5 years	Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)
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 100mm Pain VAS(Visual analogue scale) from baseline	5 years	100mm Pain VAS range is from 0 (clear) to 100 (severe)

Trial Locations

Locations (1)

Seoul national University Boramae medical center; 🇰🇷 Seoul, Korea, Republic of