Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)
NCT ID: NCT02005757
Last Updated: 2015-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-11-30
2016-10-31
Brief Summary
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Detailed Description
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2. EULAR Response after 12weeks of treatment
3. DAS28 value change
4. KHAQ-20 value change
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bredinin tablet 150mg
dosage form: Tablet, dosage: 150mg qd, Duration: for 6months
Bredinin tablet 150mg
Bredinin 150mg qd vs Bredinin 50mg tid
Bredinin tablet 50mg
dosage form: Tablet, dosage: 50mg tid, Duration: for 6months
Bredinin tablet 50mg
Bredinin 150mg qd vs Bredinin 50mg tid
Interventions
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Bredinin tablet 150mg
Bredinin 150mg qd vs Bredinin 50mg tid
Bredinin tablet 50mg
Bredinin 150mg qd vs Bredinin 50mg tid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
, Hemoglobin \< 8.5 g/dL, Platelet count \< 100,000/mm3, Serum creatinine \> 2.0 mg/dL, Aspartic Acid Transaminase/Alanine Transaminase ≥ 2\*upper limit of normal , Uric acid ≥ 1.5\*upper 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.
* 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)
20 Years
80 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Sung Su Kim, M.D., Ph.D
Role: STUDY_CHAIR
Gangneng asan Medical center
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Hallym University chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Eulji University Hospital
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Kangwon National University Hospital
Kangwon, , South Korea
Kyung Hee University hospital
Seoul, , South Korea
Soon Chun Hyang University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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32RA13007
Identifier Type: -
Identifier Source: org_study_id
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