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

Nichi-Iko Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: NI-071; Biological: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01927263

NI071F1(EFC13464)

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

NI-071

Experimental group

Treatment:

Biological: NI-071

Infliximab

Active Comparator group

Treatment:

Biological: Infliximab