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

NCT01567358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-06-19

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Infliximab

100mg/vial

BIOLOGICAL

Infliximab

100mg/vial

Sponsors & Collaborators

  • Nichi-Iko Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01567358 on ClinicalTrials.gov