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Trial record 3 of 4 for:    Nichi-Iko

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01927263
Recruitment Status : Completed
First Posted : August 22, 2013
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Nichi-Iko Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: NI-071 Biological: Infliximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: NI-071 Biological: NI-071
100mg/vial

Active Comparator: Infliximab Biological: Infliximab
100mg/vial
Other Name: Remicade




Primary Outcome Measures :
  1. Efficacy : Changes in DAS28-ESR [ Time Frame: week 0 to week 14 ]

Secondary Outcome Measures :
  1. Efficacy : Changes in DAS28 [ Time Frame: week 0 to week 54 ]
  2. Efficacy : Changes in ACR20, 50, 70 [ Time Frame: week 0 to week 54 ]
  3. Efficacy : Changes in ACR core-set [ Time Frame: week 0 to week 54 ]
  4. Safety : Long term safety (Adverse Events, Immunogenicity, etc.) [ Time Frame: to 54 weeks ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927263


Locations
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Japan
NichiIko Investigational Site
Sendai-Shi, Japan
Sponsors and Collaborators
Nichi-Iko Pharmaceutical Co., Ltd.
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Responsible Party: Nichi-Iko Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01927263    
Other Study ID Numbers: NI071F1(EFC13464)
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents