A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-

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.

Inclusion Criteria:

1. Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
2. Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit

Exclusion Criteria:

1. Patients with a following past History or concomitant diseases

   • Other Connective tissue disorders which may interfere the efficacy assessment
   • Chronic or recurrent infectious disease
   • Demyelinating disease
   • Congestive heart failure
   • lymphoproliferative disorder or myelodysplastic syndrome
   • Malignancy
   • Interstitial lung disease

2. Patients with active or latent tuberculosis or history of tuberculosis