Rheumatoid ArthritisNCT03106259
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj
An observational study of Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- FURESTEM-RA Inj.
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2016to 21 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. [NCT02221258]
Who may be able to join
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- Subject who understands and voluntarily sign an informed consent form
Who cannot join
- In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
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.
Read the detailed description
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]
- Conditions
- Rheumatoid Arthritis
- Being tested
- FURESTEM-RA Inj.
- Keywords
- FURESTEM-RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-RA Inj.Drug
Also called Not applicable-observational study
Non-interventional observational study
| Study group | Role | What they receive |
|---|---|---|
| Non-Interventional Study | Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] Receives: Drug: FURESTEM-RA Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of FURESTEM-RA Inj.
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start29 Jun 2016
- Primary completion24 Jan 2017
- Study completion21 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ki-chul Shin, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106259
- Sponsor's protocol ID
- KSTBT_FURESTEM_RA_EXT
- Status last verified
- Aug 2017
- First submitted
- 3 Apr 2017
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
- ClinicalTrials.gov ID
- NCT03106259
- Acronym / sponsor ID
- KSTBT_FURESTEM_RA_EXT
- Conditions
- Rheumatoid Arthritis
- Keywords
- FURESTEM-RA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 21 Mar 2021 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Interventional Study | – | Drug: FURESTEM-RA Inj.Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. [NCT02221258]
Key inclusion criteria (2 listed)
- Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258]
- Subject who understands and voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FURESTEM-RA Inj.Also: Not applicable-observational studyNon-interventional observational study | Drug | Non-Interventional Study |
Primary outcome
Safety of FURESTEM-RA Inj.
Time frame: 5 years
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-chul Shin principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of FURESTEM-RA Inj. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.