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

June 24, 2015 updated by: Chong Kun Dang Pharmaceutical

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Young-Il Seo, PhD
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Kyeong Min Son
      • Daejeon, Korea, Republic of
        • Recruiting
        • Eulji University Hospital
        • Contact:
        • Principal Investigator:
          • Donghyuk Sheen, PhD
      • Gangneung, Korea, Republic of
        • Recruiting
        • GangNeung Asan Hospital
        • Contact:
        • Principal Investigator:
          • Sung-Soo Kim, Ph.D
      • Kangwon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
        • Principal Investigator:
          • Kiwon Moon
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
        • Principal Investigator:
          • Seung-Jae Hong, phD
      • Seoul, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital
        • Contact:
        • Principal Investigator:
          • Hyunsook Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Mizoribine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Study Chair: Sung Su Kim, M.D., Ph.D, Gangneng asan Medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32RA13007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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