Rheumatoid ArthritisNCT04134169
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)
An observational study of Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202) 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?
- Not applicable(observational study)
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2019to 11 Apr 2026
- 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: Moderate to Severe Rheumatoid arthritis
Who may be able to join
- Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
- Subjects who understand and voluntarily sign an informed consent form
Who cannot join
- 1. Any other condition which the investigator judges would make patient unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national University Boramae medical center
Seoul
Sanghui Kim, +82-2-8703969
About this study
Official title: 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
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)
Read the 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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Not applicable(observational study)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable(observational study)Other
Not applicable(observational study)
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Not described Receives: Other: Not applicable(observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
(Rate of Adverse Event, Number of Participants with Adverse Event)
Measured: 5 years
Secondary outcomes (7)
1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
Measured: 5 years
2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
Measured: 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)
Measured: 5 years
change in KHAQ(Korean Health assessment questionnaire) from baseline
KHAQ range is from 0 (clear) to 60 (severe)
Measured: 5 years
change in CDAI (clinical disease activity index) from baseline
CDAI range is from 0 (clear) to 76 (severe)
Measured: 5 years
change in 100mm Pain VAS(Visual analogue scale) from baseline
100mm Pain VAS range is from 0 (clear) to 100 (severe)
Measured: 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)
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 posted22 Oct 2019
- Study start2 Oct 2019
- Primary completion11 Aug 2025 (estimated)
- Study completion11 Apr 2026 (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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134169
- Sponsor's protocol ID
- K0202-E
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2019
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04134169
- Acronym / sponsor ID
- K0202-E
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 11 Apr 2026 (estimated)
- First posted
- 22 Oct 2019 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | Other: Not applicable(observational study) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to Severe Rheumatoid arthritis
Key inclusion criteria (2 listed)
- Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.
- Subjects who understand and voluntarily sign an informed consent form
Key exclusion criteria (1 listed)
- 1. Any other condition which the investigator judges would make patient unsuitable for study participation
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 |
|---|---|---|
| Not applicable(observational study)Not applicable(observational study) | Other | Rheumatoid arthritis |
Primary outcome
Safety Assessment
Time frame: 5 years
(Rate of Adverse Event, Number of Participants with Adverse Event)
7 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
Time frame: 5 years
change in KHAQ(Korean Health assessment questionnaire) from baseline
Time frame: 5 years
change in CDAI (clinical disease activity index) from baseline
Time frame: 5 years
change in 100mm Pain VAS(Visual analogue scale) from baseline
Time frame: 5 years
change in Modified Sharp/Van der Heijde Socre from baseline
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 10 Oct 2022. 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?
Contact Chae Eun Jeon (+82-2-20367614, cejeon@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (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 10 Oct 2022.