Rheumatoid ArthritisNCT05835518
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jan 2023to Aug 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those diagnosed with RA or AS
Who may be able to join
- Men and women between the ages of over 19 and under 75 at the time of consent
- Patients diagnosed with RA or AS at least 3 months prior to the study registration
- Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
- Patients who have never received Adalloce
- Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study
Who cannot join
- Patients with hypersensitivity to this drug or its components
- Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
- Patients with moderate to severe heart failure (NYHA class III/IV)
- Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
- Patients who are not suitable for participation in this study according to the judgment of the investigator
- Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Daegu Catholic University Medical Center
Daegu
Jeongyoon Choi
About this study
Official title: An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- The Efficacy and Safety of Adalloce
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start26 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completionAug 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.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeongyoon Choi, PI, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835518
- Sponsor's protocol ID
- YMC049
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT05835518
- Acronym / sponsor ID
- YMC049
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- The Efficacy and Safety of Adalloce
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 28 Apr 2023 (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.
This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those diagnosed with RA or AS
Key inclusion criteria (5 listed)
- Men and women between the ages of over 19 and under 75 at the time of consent
- Patients diagnosed with RA or AS at least 3 months prior to the study registration
- Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
- Patients who have never received Adalloce
- Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study
Key exclusion criteria (6 listed)
- Patients with hypersensitivity to this drug or its components
- Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
- Patients with moderate to severe heart failure (NYHA class III/IV)
- Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
- Patients who are not suitable for participation in this study according to the judgment of the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS
Time frame: 52weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
Jeongyoon Choi, PI principal investigator
Daegu Catholic University 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 and Ankylosing Spondylitis, run by Yuhan Corporation 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 5 inclusion and 6 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 May 2023. 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 Hee Suh (+82-2-828-0231, hee1110@yuhan.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS (time frame: 52weeks). 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 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.