At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 548 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 Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating CT-P13 SC (Infliximab) and Placebo SC for Ulcerative Colitis. Completed, enrolled 548 participants across 1 site.
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 Ulcerative Colitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartSep 2020
Primary CompletionJul 2022
Study CompletionJul 2023
TodayJul 2026
First PostedDec 19, 2019
Enrollment StartSep 1, 2020
Primary CompletionJul 7, 2022
Study CompletionJul 11, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.5 years ago
Interventions
CT-P13 SC (Infliximab)biological
Subcutaneous injection of CT-P13 SC
Placebo SCother
Subcutaneous injection of Placebo SC