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Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED) (AMOLED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02005757
Recruitment Status : Unknown
Verified June 2015 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Bredinin tablet 150mg Drug: Bredinin tablet 50mg Phase 2

Detailed Description:
  1. EULAR Response after 24weeks of treatment
  2. EULAR Response after 12weeks of treatment
  3. DAS28 value change
  4. KHAQ-20 value change

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bredinin tablet 150mg
dosage form: Tablet, dosage: 150mg qd, Duration: for 6months
Drug: Bredinin tablet 150mg
Bredinin 150mg qd vs Bredinin 50mg tid
Other Name: Mizoribine

Active Comparator: Bredinin tablet 50mg
dosage form: Tablet, dosage: 50mg tid, Duration: for 6months
Drug: Bredinin tablet 50mg
Bredinin 150mg qd vs Bredinin 50mg tid
Other Name: Mizoribine




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005757


Contacts
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Contact: Sung Su Kim, M.D., Ph.D 82-33-610-3126 DrKiss@korea.com

Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Young-Il Seo, PhD       yiseo@hallym.or.kr   
Principal Investigator: Young-Il Seo, PhD         
Hallym University chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Kyeong Min Son, PhD       jollyfox@hanmail.net   
Principal Investigator: Kyeong Min Son         
Eulji University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Donghyuk Sheen, PhD       rheuma@eulji.ac.kr   
Principal Investigator: Donghyuk Sheen, PhD         
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sung-Soo Kim, Ph.D    82-33-610-3061    drkiss@ulsan.ac.kr   
Principal Investigator: Sung-Soo Kim, Ph.D         
Kangwon National University Hospital Recruiting
Kangwon, Korea, Republic of
Contact: Kiwon Moon, PhD       kiwonmoon@kangwon.ac.kr   
Principal Investigator: Kiwon Moon         
Kyung Hee University hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jae Hong, phD       hsj718@khu.ac.kr   
Principal Investigator: Seung-Jae Hong, phD         
Soon Chun Hyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun-sook Kim, PhD       healthyra@schmc.ac.kr   
Principal Investigator: Hyunsook Kim         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Study Chair: Sung Su Kim, M.D., Ph.D Gangneng asan Medical center

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02005757     History of Changes
Other Study ID Numbers: 32RA13007
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by Chong Kun Dang Pharmaceutical:
rheumatoid arthritis
RA
Mizoribine
DAS28
European League Against Rheumatism

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mizoribine
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors