search
Back to results

Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Infliximab
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. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
  2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit

Exclusion Criteria:

  1. History of following diseases

    • Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
    • Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
    • Severe infectious disease（hepatitis, pneumonia、sepsis）
    • History of demyelinating disease or multiple sclerosis
    • Congestive heart failure
    • lymphoproliferative disorder or myelodysplastic syndrome
    • History of malignancy
    • Interstitial lung disease
  2. Patients with active or latent tuberculosis or history of tuberculosis

Sites / Locations

  • 392001001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NI-071

Remicade

Arm Description

Outcomes

Primary Outcome Measures

Safety : Incidence of Adverse Events

Secondary Outcome Measures

PK : Area under the serum concentration versus time curve(AUC)
Efficacy : ACR core-set

Full Information

First Posted
March 23, 2012
Last Updated
June 18, 2013
Sponsor
Nichi-Iko Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01567358
Brief Title
Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
Official Title
A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (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 compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with 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 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NI-071
Arm Type
Experimental
Arm Title
Remicade
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Infliximab
Intervention Description
100mg/vial
Intervention Type
Biological
Intervention Name(s)
Infliximab
Intervention Description
100mg/vial
Primary Outcome Measure Information:
Title
Safety : Incidence of Adverse Events
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
PK : Area under the serum concentration versus time curve(AUC)
Time Frame
14 weeks
Title
Efficacy : ACR core-set
Time Frame
14 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: Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit Exclusion Criteria: History of following diseases Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.） Severe infectious disease（hepatitis, pneumonia、sepsis） History of demyelinating disease or multiple sclerosis Congestive heart failure lymphoproliferative disorder or myelodysplastic syndrome History of malignancy Interstitial lung disease Patients with active or latent tuberculosis or history of tuberculosis
Facility Information:
Facility Name
392001001
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-0032
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs