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

Kang Stem Biotech Co., Ltd.9 enrolled

Overview

Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.

This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis. Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. \[NCT02221258\]

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

FURESTEM-RA Inj.DRUG

Non-interventional observational study

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\[NCT02221258\] * Subject who understands and voluntarily sign an informed consent form Exclusion Criteria: * In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period

Locations (1)

Seoul national University Boramae medical center

Seoul, South Korea

Outcomes

Primary Outcomes

Safety of FURESTEM-RA Inj.

Evaluate the number of adverse events Safety of FURESTEM-RA Inj.

Time frame: 5 years

Data from ClinicalTrials.gov

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