A Multicenter, randomized, controlled, parallel group, open, 32-week study to assess the non-inferiority of methotrexate(MTX) and Leflunomide(LEF) combination therapy compared to triple combination(MTX, Hydroxychloroquine(HCQ), Sulfasalazine(SSZ)) therapy in MTX inadequate response rheumatoid arthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 190
(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
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DAS28-CRP(24week) compared to Baseline
- Secondary Outcome Measures
Name Time Method DAS28-CRP(12, 16, 32week) compared to Baseline;Low Disease Activity Ratio(12, 16, 24, 32week);Remission Ratio(12, 16, 24week);Adverse event