Rheumatoid Arthritis
Conditions
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
Interventions
Not applicable(observational study)
Sponsors
Kang Stem Biotech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 5 years | (Rate of Adverse Event, Number of Participants with Adverse Event) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate | 5 years | — |
| 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 KHAQ(Korean Health assessment questionnaire) from baseline | 5 years | KHAQ range is from 0 (clear) to 60 (severe) |
| 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 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) |
| 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) |
| change in CDAI (clinical disease activity index) from baseline | 5 years | CDAI range is from 0 (clear) to 76 (severe) |
Countries
South Korea
Contacts
Primary ContactChae Eun Jeon
Outcome results
None listed