Rheumatoid ArthritisPhase 2AMOLEDNCT02005757
Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)
A Phase 2 study testing Bredinin tablet 150mg and Bredinin tablet 50mg in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 7 sites in South Korea.
Trial summary
The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Bredinin tablet 150mg and Bredinin tablet 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Nov 2013to Oct 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged from 20 to 80 years old
- Signed and dated informed consent document indicating that the patient
- Patients must have a diagnosis of Rheumatoid Arthritis(RA) of at least 3months duration as defined by the 2010 American College of Rheumatology(ACR) Classification criteria.
- Patients should have a Disease Activity Score 28 greater than or equal to 3.2 (DAS28 ≥ 3.2) and have received treatment with more than 1 kind of disease-modifying antirheumatic drug(including MTX).
- ESR≥28mm/h or CRP≥1.0mg/dl at screening.
Who cannot join
- At screening, patients have laboratory result as defined by : white blood cell ≤ 3,000/mm3
- , Hemoglobin < 8.5 g/dL, Platelet count < 100,000/mm3, Serum creatinine > 2.0 mg/dL, Aspartic Acid Transaminase/Alanine Transaminase ≥ 2upper limit of normal , Uric acid ≥ 1.5upper limit of normal
- Patient must not have bleeding disorder or taking anticoagulant. (But, lt is allowed to take 100mg/day of Asprin)
- Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
- Patients have severe infection, including moderate respiratory disease and have received treatment with systemic antibiotics within 2 weeks.
- Patients have cardiovascular disease or associated disease which is not controlled.
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- Patients have a history of malignancy within 5years. (But, basal cell or squamous cell carcinoma or carcinoma in situ of the uterine cervix have been treated is allowed)
- Patients have hypersensitivity reaction on this drug.
- Patients on any other clinical trial or experimental treatment in the past 3months.
- Female patients who are breast feeding, pregnant or plan to become pregnant during the trial or for two months following study termination.
- Not allowable medication recorded below ; Intra-articular injections within weeks at baseline visit, Patients taking oral steroid over 10mg /day or using new treatment or changing dosage within 4weeks at baseline visit, Using new nonsteroidal antiinflammatory drug within 4 weeks or changing nonsteroidal antiinflammatory drug dosage within 2 weeks at baseline visit.
- Having experience of use biologic agent, immunosuppressant, cytostatic preparations within 8weeks at baseline visit. (But, Rituximab is not allowed within 6months)
- Start to treatment new disease-modifying antirheumatic drug or need to change dosage of disease-modifying antirheumatic drug which is taking on the trial. (Leflunomide(ARAVA®) is not allowed within 12weeks, But, Cholestyramine is allowed after 48 hours later stopping. if it use three times a day, 8g, for 11days)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang
Young-Il Seo, PhD, yiseo@hallym.or.kr
Young-Il Seo, PhD
- Recruiting
Hallym University chuncheon Sacred Heart Hospital
Chuncheon
Kyeong Min Son, PhD, jollyfox@hanmail.net
Kyeong Min Son
- Recruiting
Eulji University Hospital
Daejeon
Donghyuk Sheen, PhD, rheuma@eulji.ac.kr
Donghyuk Sheen, PhD
- Recruiting
Gangneung Asan Hospital
Gangneung
Sung-Soo Kim, Ph.D, 82-33-610-3061, drkiss@ulsan.ac.kr
Sung-Soo Kim, Ph.D
- Recruiting
Kangwon National University Hospital
Kangwon
Kiwon Moon, PhD, kiwonmoon@kangwon.ac.kr
Kiwon Moon
- Recruiting
Kyung Hee University hospital
Seoul
Seung-Jae Hong, phD, hsj718@khu.ac.kr
Seung-Jae Hong, phD
- Recruiting
Soon Chun Hyang University Hospital
Seoul
Hyun-sook Kim, PhD, healthyra@schmc.ac.kr
Hyunsook Kim
About this study
Official title: Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug
The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.
Read the detailed description
- EULAR Response after 24weeks of treatment
- EULAR Response after 12weeks of treatment
- DAS28 value change
- KHAQ-20 value change
- Conditions
- Rheumatoid Arthritis
- Being tested
- Bredinin tablet 150mg, Bredinin tablet 50mg
- Keywords
- rheumatoid arthritis, RA, Mizoribine, DAS28, European League Against Rheumatism
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bredinin tablet 150mgDrug
Also called Mizoribine
Bredinin 150mg qd vs Bredinin 50mg tid
Bredinin tablet 50mgDrug
Also called Mizoribine
Bredinin 150mg qd vs Bredinin 50mg tid
| Study group | Role | What they receive |
|---|---|---|
| Bredinin tablet 150mg | Experimental | dosage form: Tablet, dosage: 150mg qd, Duration: for 6months Receives: Drug: Bredinin tablet 150mg |
| Bredinin tablet 50mg | Active comparator | dosage form: Tablet, dosage: 50mg tid, Duration: for 6months Receives: Drug: Bredinin tablet 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (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 Chong Kun Dang PharmaceuticalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Su Kim, M.D., Ph.D, Study chair, Gangneng asan Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005757
- Sponsor's protocol ID
- 32RA13007
- Acronym
- AMOLED
- Status last verified
- Jun 2015
- First submitted
- 4 Dec 2013
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug
- ClinicalTrials.gov ID
- NCT02005757
- Acronym / sponsor ID
- AMOLED / 32RA13007
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, RA, Mizoribine, DAS28, European League Against Rheumatism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- 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.
The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug.
Detailed description
- EULAR Response after 24weeks of treatment
- EULAR Response after 12weeks of treatment
- DAS28 value change
- KHAQ-20 value change
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bredinin tablet 150mg | Experimental | Drug: Bredinin tablet 150mgdosage form: Tablet, dosage: 150mg qd, Duration: for 6months |
| Bredinin tablet 50mg | Active comparator | Drug: Bredinin tablet 50mgdosage form: Tablet, dosage: 50mg tid, Duration: for 6months |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged from 20 to 80 years old
- Signed and dated informed consent document indicating that the patient
- Patients must have a diagnosis of Rheumatoid Arthritis(RA) of at least 3months duration as defined by the 2010 American College of Rheumatology(ACR) Classification criteria.
- Patients should have a Disease Activity Score 28 greater than or equal to 3.2 (DAS28 ≥ 3.2) and have received treatment with more than 1 kind of disease-modifying antirheumatic drug(including MTX).
- ESR≥28mm/h or CRP≥1.0mg/dl at screening.
Key exclusion criteria (13 listed)
- At screening, patients have laboratory result as defined by : white blood cell ≤ 3,000/mm3
- , Hemoglobin < 8.5 g/dL, Platelet count < 100,000/mm3, Serum creatinine > 2.0 mg/dL, Aspartic Acid Transaminase/Alanine Transaminase ≥ 2upper limit of normal , Uric acid ≥ 1.5upper limit of normal
- Patient must not have bleeding disorder or taking anticoagulant. (But, lt is allowed to take 100mg/day of Asprin)
- Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
- Patients have severe infection, including moderate respiratory disease and have received treatment with systemic antibiotics within 2 weeks.
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 |
|---|---|---|
| Bredinin tablet 150mgAlso: MizoribineBredinin 150mg qd vs Bredinin 50mg tid | Drug | Bredinin tablet 150mg |
| Bredinin tablet 50mgAlso: MizoribineBredinin 150mg qd vs Bredinin 50mg tid | Drug | Bredinin tablet 50mg |
Primary outcome
all cause mortality
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Sung Su Kim, M.D., Ph.D study chair
Gangneng asan Medical center
7 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 Bredinin tablet 150mg and Bredinin tablet 50mg in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 7 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 5 inclusion and 13 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 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Su Kim, M.D., Ph.D (82-33-610-3126, DrKiss@korea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: two 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 26 Jun 2015.