Long-term evaluation of FURESTEM-RA for rheumatoid arthritis
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
Kang Stem Biotech Co., Ltd. · NCT04134169
This study is testing the long-term safety and effectiveness of a treatment called FURESTEM-RA in people with moderate to severe rheumatoid arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Kang Stem Biotech Co., Ltd. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04134169 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety and efficacy of FURESTEM-RA Inj in patients with moderate to severe rheumatoid arthritis. It involves a multi-center approach, following participants who have previously enrolled in the K0202 clinical trial and received multiple medications. The study will collect data over a five-year period to monitor outcomes and any adverse effects associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are patients who have previously participated in the K0202 clinical trial and have been treated with more than one medication for their rheumatoid arthritis.
Not a fit: Patients with other conditions that may render them unsuitable for participation, as determined by the investigator, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of FURESTEM-RA for managing rheumatoid arthritis.
How similar studies have performed: While this study is observational, similar long-term studies have provided valuable data on treatment safety and efficacy, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Seoul national University Boramae medical center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Chae Eun Jeon
- Email: cejeon@kangstem.com
- Phone: +82-2-20367614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatoid Arthritis