At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 396 enrolled
Drug / intervention
CT-P13 SC (Infliximab) +1 morebiological
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, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating CT-P13 SC (Infliximab) and Placebo SC for Crohn's Disease. Completed, enrolled 396 participants across 29 sites in 26 countries.
Detailed Summary
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesBelarus, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Moldova, Peru, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartOct 2019
Primary CompletionAug 2022
Study CompletionAug 2023
TodayJul 2026
First PostedMay 10, 2019
Enrollment StartOct 28, 2019
Primary CompletionAug 23, 2022
Study CompletionAug 22, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.1 years ago
Interventions
CT-P13 SC (Infliximab)biological
Subcutaneous injection of CT-P13 SC
Placebo SCother
Subcutaneous injection of Placebo SC