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

April 6, 2016 updated by: Nichi-Iko Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Sendai-Shi, Japan
        • NichiIko Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NI-071
Biological: NI-071
100mg/vial
Active Comparator: Infliximab
Biological: Infliximab
100mg/vial
Other Names:
  • Remicade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy : Changes in DAS28-ESR
Time Frame: week 0 to week 14
week 0 to week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy : Changes in DAS28
Time Frame: week 0 to week 54
week 0 to week 54
Efficacy : Changes in ACR20, 50, 70
Time Frame: week 0 to week 54
week 0 to week 54
Efficacy : Changes in ACR core-set
Time Frame: week 0 to week 54
week 0 to week 54
Safety : Long term safety (Adverse Events, Immunogenicity, etc.)
Time Frame: to 54 weeks
to 54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 9, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 22, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI071F1(EFC13464)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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