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Completed

NCT Number: NCT01927263

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NichiIko Investigational Site

Sendai, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NI-071

Biological

100mg/vial

Infliximab

Biological

100mg/vial

Other names: Remicade

Primary outcomes

  1. Efficacy : Changes in DAS28-ESR

    Time frame: week 0 to week 14

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nichi-Iko Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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-

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 22, 2013
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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