ClinicalTrials.gg
RecruitingNCT05835518Updated May 9, 2023

An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

An observational study in Rheumatoid Arthritis and Ankylosing Spondylitis, sponsored by Yuhan Corporation. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Yuhan Corporation · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
19 Years to 74 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
12th of 33
1,000 · median 425
Started
2023
with 6 others
Observational
33 of 188
5 open now
Primary completion
2025-12
later than 3 of 15 live
Registered
177th of 188
by date

Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, this one is the 12th largest by planned enrollment of the 33 observational ones that give a count, is one of 7 that started in 2023, is one of 33 observational ones, reaches primary completion later than 3 of the 15 other live ones, and was the 177th 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 74 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
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

This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study

03

Conditions studied

  • Rheumatoid Arthritis
  • Ankylosing Spondylitis

Keywords

  • The Efficacy and Safety of Adalloce
04

Who can participate

Ages eligible
19 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Those diagnosed with RA or AS

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. Men and women between the ages of over 19 and under 75 at the time of consent
  2. Patients diagnosed with RA or AS at least 3 months prior to the study registration
  3. Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
  4. Patients who have never received Adalloce
  5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study

Exclusion criteria

Exclusion Criteria:

  1. Patients with to this drug or its components
  2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
  3. Patients with moderate to severe heart failure ( class III/IV)
  4. Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
  5. Patients who are not suitable for participation in this study according to the judgment of the investigator
  6. Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)
Terms in these criteria, in plain language(2)

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS

    Time frame: 52weeks

07

Study locations

1 of 1 sites recruiting
08

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 Jan 2023 (actual). Primary completion is estimated for Dec 2025, 35 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 35 months is below 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
Apr 18, 2023
First posted
Apr 28, 2023
StartActual
Jan 26, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Aug 2026
Last update
May 9, 2023
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 May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05835518
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Apr 28, 2023
Start date
Jan 26, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Aug 2026 (estimated)
Last update
May 9, 2023

Study contacts

Hee Suh
Contact
hee1110@yuhan.co.kr
+82-2-828-0231
Jeongyoon Choi, PI
principal investigator · Daegu Catholic University Medical Center

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion