None listed
Conditions
Interventions
Drug : Orally administered as follows for a total of 32 weeks.
Test Group
(1) Leflunomide(LEF)
Leflunomide can be started at 10 mg/day and increased to 20 mg/day at visit3(4 weeks), visit4(8 weeks), a
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The patients are older then 19 years old, at the time of signing the subject consent form (2) A patient who has voluntarily decided to participate in the clinical trial after hearing the explanation about this clinical trial, (3) Patients diagnosed with rheumatoid arthritis at least 2 months before screening (4) Patients with active rheumatoid arthritis with DAS28-CRP=3.2 at screening and baseline
Exclusion criteria
Exclusion criteria: (1) Currently, patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, thyroid, blood, psychoneurologic, or metabolic/electrolyte abnormalities. (2) Patients who have a history of any of the following diseases or are currently accompanied by the following diseases ? Sepsis ? Demyelinating disorders, Multiple sclerosis, Guillain-Barre syndrome, etc. ? Lymphoproliferative diseases (3) Patients with a history of any of the following diseases within 24 weeks prior to the first administration of the investigational drug or who are currently accompanied by the following diseases ? Serious infectious disease* *: Pneumocystis pneumonia, Pyelonephritis, etc. ? Opportunistic infection* *: Cytomegalovirus infection, Herpes zoster, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28-CRP(24week) compared to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28-CRP(12, 16, 32week) compared to Baseline;Low Disease Activity Ratio(12, 16, 24, 32week);Remission Ratio(12, 16, 24week);Adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactWan-Uk Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed