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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT02005757 |
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Date of registration:
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04/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)
AMOLED |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02005757 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sung Su Kim, M.D., Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gangneng asan Medical center |
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Name:
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Sung Su Kim, M.D., Ph.D |
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Address:
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Telephone:
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82-33-610-3126 |
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Email:
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DrKiss@korea.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria
- 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 = 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)
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Bredinin tablet 150mg
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Drug: Bredinin tablet 50mg
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Primary Outcome(s)
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all cause mortality
[Time Frame: two years]
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Secondary ID(s)
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32RA13007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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