NCT01927263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

August 9, 2013

Last Update Submit

April 6, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy : Changes in DAS28-ESR

    week 0 to week 14

Secondary Outcomes (4)

  • Efficacy : Changes in DAS28

    week 0 to week 54

  • Efficacy : Changes in ACR20, 50, 70

    week 0 to week 54

  • Efficacy : Changes in ACR core-set

    week 0 to week 54

  • Safety : Long term safety (Adverse Events, Immunogenicity, etc.)

    to 54 weeks

Study Arms (2)

NI-071

EXPERIMENTAL
Biological: NI-071

Infliximab

ACTIVE COMPARATOR
Biological: Infliximab

Interventions

NI-071BIOLOGICAL

100mg/vial

NI-071
InfliximabBIOLOGICAL

100mg/vial

Also known as: Remicade
Infliximab

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NichiIko Investigational Site

Sendai, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 22, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

JP(1)