MedTrace Logo

A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)

NCT02990806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 683

Last updated 2023-01-30

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).

Conditions

Interventions

DRUG

NI-071

IV infusion.

DRUG

Remicade

IV infusion.

Sponsors & Collaborators

  • Nichi-Iko Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2019-05-20
Completion
2019-05-20
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

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 NCT02990806 on ClinicalTrials.gov