At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 683 enrolled
Drug / intervention
NI-071 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating NI-071 and Remicade for Rheumatoid Arthritis. Completed, enrolled 683 participants across 134 sites in 8 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCzechia, Poland, Puerto Rico, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionMay 2019
TodayJul 2026
First PostedDec 13, 2016
Enrollment StartJan 19, 2017
Primary CompletionMay 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.6 years ago
Interventions
NI-071drug
IV infusion.
Remicadedrug
IV infusion.