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

Kang Stem Biotech Co., Ltd.28 enrolled

Overview

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

Conditions

Rheumatoid Arthritis

Interventions

Not applicable(observational study)OTHER

Not applicable(observational study)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul national University Boramae medical center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Safety Assessment

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

Time frame: 5 years

Secondary Outcomes

1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate

Time frame: 5 years

2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate

Time frame: 5 years

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)

Time frame: 5 years

change in KHAQ(Korean Health assessment questionnaire) from baseline

KHAQ range is from 0 (clear) to 60 (severe)

Time frame: 5 years

change in CDAI (clinical disease activity index) from baseline

CDAI range is from 0 (clear) to 76 (severe)

Time frame: 5 years

change in 100mm Pain VAS(Visual analogue scale) from baseline

100mm Pain VAS range is from 0 (clear) to 100 (severe)

Time frame: 5 years

change in Modified Sharp/Van der Heijde Socre from baseline

Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)

Time frame: 5 years

Central Contacts

Chae Eun Jeon

CONTACT

+82-2-20367614 cejeon@kangstem.com

Data from ClinicalTrials.gov

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