A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
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The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit
Patients with a following past History or concomitant diseases
Other Connective tissue disorders which may interfere the efficacy assessment
Chronic or recurrent infectious disease
Congestive heart failure
lymphoproliferative disorder or myelodysplastic syndrome
Interstitial lung disease
Patients with active or latent tuberculosis or history of tuberculosis