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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NI-071
Infliximab
Sponsored by
Nichi-Iko Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NichiIko Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NI-071

Infliximab

Arm Description

Outcomes

Primary Outcome Measures

Efficacy : Changes in DAS28-ESR

Secondary Outcome Measures

Efficacy : Changes in DAS28
Efficacy : Changes in ACR20, 50, 70
Efficacy : Changes in ACR core-set
Safety : Long term safety (Adverse Events, Immunogenicity, etc.)

Full Information

First Posted
August 9, 2013
Last Updated
April 6, 2016
Sponsor
Nichi-Iko Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01927263
Brief Title
A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
Official Title
A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nichi-Iko Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NI-071
Arm Type
Experimental
Arm Title
Infliximab
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
NI-071
Intervention Description
100mg/vial
Intervention Type
Biological
Intervention Name(s)
Infliximab
Other Intervention Name(s)
Remicade
Intervention Description
100mg/vial
Primary Outcome Measure Information:
Title
Efficacy : Changes in DAS28-ESR
Time Frame
week 0 to week 14
Secondary Outcome Measure Information:
Title
Efficacy : Changes in DAS28
Time Frame
week 0 to week 54
Title
Efficacy : Changes in ACR20, 50, 70
Time Frame
week 0 to week 54
Title
Efficacy : Changes in ACR core-set
Time Frame
week 0 to week 54
Title
Safety : Long term safety (Adverse Events, Immunogenicity, etc.)
Time Frame
to 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Patients with active or latent tuberculosis or history of tuberculosis
Facility Information:
Facility Name
NichiIko Investigational Site
City
Sendai-Shi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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