Clinical trial NCT02005757: Efficacy and Safety Study of Mizoribine in Active Rheumatoid (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
RA
Mizoribine
DAS28
European League Against Rheumatism
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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)

Primary outcomes:
measure: all cause mortality
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University chuncheon Sacred Heart Hospital
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Kangwon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
Study officials:
affiliation: Gangneng asan Medical center
name: Sung Su Kim, M.D., Ph.D
role: STUDY_CHAIR
References: