ClinicalTrials.gg
RecruitingNCT04134169Updated Oct 10, 2022

Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)

An observational study in Rheumatoid Arthritis, sponsored by Kang Stem Biotech Co., Ltd.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by Kang Stem Biotech Co., Ltd. · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2019; still recruiting 7 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
28
Ages
19 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of — 10 open to participants now, 16 under way, 2 of them phase 3. Arthritis, Rheumatoid · Korea, Republic of.

Planned enrollment
31st of 33
28 · median 425
Started
2019
with 5 others
Observational
33 of 188
5 open now
Primary completion
2025-08
later than 1 of 15 live
Registered
163rd of 188
by date

Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, this one is the 31st largest by planned enrollment of the 33 observational ones that give a count, is one of 6 that started in 2019, is one of 33 observational ones, reaches primary completion later than 1 of the 15 other live ones, and was the 163rd registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

10 of the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 19 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Rheumatoid Arthritis
04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Moderate to Severe Rheumatoid arthritis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form

Exclusion criteria

Exclusion Criteria:

  1. Any other condition which the investigator judges would make patient unsuitable for study participation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
28 participants (estimated)
Patient registry
No

Groups and cohorts

  • Rheumatoid arthritis

    Other: Not applicable(observational study)

Interventions

  • OtherNot applicable(observational study)

    Not applicable(observational study)

06

What researchers measure

Primary outcomes

  1. Safety Assessment

    (Rate of Adverse Event, Number of Participants with Adverse Event)

    Time frame: 5 years

Secondary outcomes

  1. 1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate

    Time frame: 5 years

  2. 2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate

    Time frame: 5 years

  3. 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)

    Time frame: 5 years

  4. change in KHAQ(Korean Health assessment questionnaire) from baseline

    KHAQ range is from 0 (clear) to 60 (severe)

    Time frame: 5 years

  5. change in CDAI (clinical disease activity index) from baseline

    CDAI range is from 0 (clear) to 76 (severe)

    Time frame: 5 years

  6. change in 100mm Pain VAS(Visual analogue scale) from baseline

    100mm Pain VAS range is from 0 (clear) to 100 (severe)

    Time frame: 5 years

  7. change in Modified Sharp/Van der Heijde Socre from baseline

    Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Seoul national University Boramae medical center
    Seoul, Korea, Republic of
    Recruiting
    • Sanghui Kim · Contact+82-2-8703969
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Aug 2025, 70 months after the start.

Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's planned 70 months is above that.

Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2019
First posted
Oct 22, 2019
StartActual
Oct 2, 2019
Primary completionEst.
Aug 11, 2025
CompletionEst.
Apr 11, 2026
Last update
Oct 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04134169
Lead sponsor
Kang Stem Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Oct 22, 2019
Start date
Oct 2, 2019
Primary completion
Aug 11, 2025 (estimated)
Completion
Apr 11, 2026 (estimated)
Last update
Oct 10, 2022

Study contacts

Chae Eun Jeon
Contact
cejeon@kangstem.com
+82-2-20367614

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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