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

Rheumatoid Arthritis Clinical Trial

— AMOLED  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02005757
• Other study ID #: 32RA13007
• Status: Recruiting
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: June 24, 2015
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: June 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: Sung Su Kim, M.D., Ph.D
• Phone: 82-33-610-3126
• Email: DrKiss[@]korea.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

1. EULAR Response after 24weeks of treatment

2. EULAR Response after 12weeks of treatment

3. DAS28 value change

4. KHAQ-20 value change

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Bredinin tablet 150mg
Bredinin 150mg qd vs Bredinin 50mg tid
• Bredinin tablet 50mg
Bredinin 150mg qd vs Bredinin 50mg tid

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Hallym University chuncheon Sacred Heart Hospital	Chuncheon
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Kangwon National University Hospital	Kangwon
Korea, Republic of	Kyung Hee University hospital	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		two years	No