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

Phase 2

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Bredinin tablet 150mg; Drug: Bredinin tablet 50mg

• Registration Number: NCT02005757
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-26
• Primary Completion: 2016-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bredinin tablet 150mg	Bredinin tablet 150mg	dosage form: Tablet, dosage: 150mg qd, Duration: for 6months
Bredinin tablet 50mg	Bredinin tablet 50mg	dosage form: Tablet, dosage: 50mg tid, Duration: for 6months

Primary Outcome Measures

Name	Time	Method
all cause mortality	two years

Trial Locations

Locations (7)

Eulji University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Kangwon, Korea, Republic of

Soon Chun Hyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Hallym University chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Kyung Hee University hospital; 🇰🇷 Seoul, Korea, Republic of