Rheumatoid ArthritisPhase 2NCT03275025
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
A Phase 2 study testing YRA-1909 low dose, YRA-1909 mid dose and YRA-1909 high dose in people with Rheumatoid Arthritis, run by Yungjin Pharm. Co., Ltd. at 14 sites in South Korea.
Trial summary
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR). 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?
- YRA-1909 low dose, YRA-1909 mid dose and YRA-1909 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 1 Apr 2017to 19 Nov 2019
- Phase
- Phase 2
- 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
Who may be able to join
- 19 Years to 80 Years
- Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
- Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
Who cannot join
- Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening
- Any of the following laboratory values at screening:
- Patients with severe liver impairment (AST or ALT > 2 times the upper limit of normal)
- Patients with renal disease,immunodeficiency disease and peptic ulcer
- Patients with pleural effusion and ascites
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Hanllym University Medical Center
Anyang
Chungbuk National University Hospital
Chungju
Kelmyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Kyung Hee University Hospital at Gangdong
Gangdong
Chonnam National University Hospital
Gwangju
Gachon University Gil Medical Center
Incheon
Chonbuk National University Hospital
Jeonju
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul, Jongno-gu, 110744
Hanyang University Seoul Hospital
Seoul
KyungHee University Hospital
Seoul
Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
- Conditions
- Rheumatoid Arthritis
- Being tested
- YRA-1909 low dose, YRA-1909 mid dose, YRA-1909 high dose, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YRA-1909 low doseDrug
A low dose of YRA-1909; daily oral intake for 12 weeks
YRA-1909 mid doseDrug
A mid dose of YRA-1909; daily oral intake for 12 weeks
YRA-1909 high doseDrug
A high dose of YRA-1909; daily oral intake for 12 weeks
PlaceboDrug
Matching placebo dosing with daily oral intake for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| YRA-1909 low dose | Experimental | Not described Receives: Drug: YRA-1909 low dose; Drug: Placebo |
| YRA-1909 medium does | Experimental | Not described Receives: Drug: YRA-1909 mid dose; Drug: Placebo |
| YRA-1909 high dose | Experimental | Not described Receives: Drug: YRA-1909 high dose |
| YRA-1909 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20 (ACR20) response rate at Week 12
Measured: Week 12
Percentage of Participants With Adverse Events
Incidence of all grade adverse events
Measured: Week 12
Secondary outcomes (7)
ACR20 Response at Week 4,8
Measured: Week 4 and 8
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
Measured: Week 4,8 and 12
ACR 50, 70 Response at Week 4, 8 and 12
Measured: Week 4, 8 and 12
Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
Measured: Week 4, 8 and 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
Measured: Week 4, 8 and 12
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
Measured: Weeks 4, 8 and 12
Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator
Measured: Week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Apr 2017
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yungjin Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YeongWook Song, M.D.,Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275025
- Sponsor's protocol ID
- YJ15-201
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2017
- Last updated
- 3 May 2021
- 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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
- ClinicalTrials.gov ID
- NCT03275025
- Acronym / sponsor ID
- YJ15-201
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 7 Sep 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.
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YRA-1909 low dose | Experimental | Drug: YRA-1909 low dose, Drug: Placebo |
| YRA-1909 medium does | Experimental | Drug: YRA-1909 mid dose, Drug: Placebo |
| YRA-1909 high dose | Experimental | Drug: YRA-1909 high dose |
| YRA-1909 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 Years to 80 Years
- Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
- Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
Key exclusion criteria (5 listed)
- Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening
- Any of the following laboratory values at screening:
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 |
|---|---|---|
| YRA-1909 low doseA low dose of YRA-1909; daily oral intake for 12 weeks | Drug | YRA-1909 low dose |
| YRA-1909 mid doseA mid dose of YRA-1909; daily oral intake for 12 weeks | Drug | YRA-1909 medium does |
| YRA-1909 high doseA high dose of YRA-1909; daily oral intake for 12 weeks | Drug | YRA-1909 high dose |
| PlaceboMatching placebo dosing with daily oral intake for 12 weeks | Drug | YRA-1909 Placebo, YRA-1909 low dose, YRA-1909 medium does |
Primary outcome
American College of Rheumatology 20 (ACR20) response rate at Week 12
Time frame: Week 12
Percentage of Participants With Adverse Events
Time frame: Week 12
Incidence of all grade adverse events
7 secondary outcomes
ACR20 Response at Week 4,8
Time frame: Week 4 and 8
Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
Time frame: Week 4,8 and 12
ACR 50, 70 Response at Week 4, 8 and 12
Time frame: Week 4, 8 and 12
Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
Time frame: Week 4, 8 and 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
Time frame: Week 4, 8 and 12
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
Time frame: Weeks 4, 8 and 12
Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator
Time frame: Week 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- 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.
YeongWook Song, M.D.,Ph.D. study chair
Seoul National University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YRA-1909 low dose, YRA-1909 mid dose and YRA-1909 high dose in people with Rheumatoid Arthritis, run by Yungjin Pharm. Co., Ltd. at 14 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
American College of Rheumatology 20 (ACR20) response rate at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 3 May 2021.