Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
2 other identifiers
interventional
220
1 country
1
Brief Summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
September 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2017
CompletedResults Posted
Study results publicly available
April 11, 2018
CompletedMay 9, 2018
March 1, 2018
1.3 years
March 24, 2014
February 14, 2018
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
at Week 6
Secondary Outcomes (7)
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
Week 30
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
Week 54
The Number and Percentage of Patients Achieving Clinical Remission at Week 6
Week 6
The Number and Percentage of Patients Achieving Clinical Remission at Week 30
Week 30
The Number and Percentage of Patients Achieving Clinical Remission at Week 54
Week 54
- +2 more secondary outcomes
Study Arms (4)
CT-P13 - CT-P13
EXPERIMENTALCT-P13 followed by CT-P13 from Week 30
CT-P13 - Remicade
ACTIVE COMPARATORCT-P13 followed by Remicade from Week 30
Remicade - Remicade
ACTIVE COMPARATORRemicade followed by Remicade from Week 30
Remicade - CT-P13
EXPERIMENTALRemicade followed by CT-P13 from Week 30
Interventions
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Eligibility Criteria
You may qualify if:
- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
You may not qualify if:
- Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
- Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Related Publications (5)
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
PMID: 35435862DERIVEDDulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
PMID: 34216825DERIVEDWong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242.
PMID: 33245751DERIVEDYe BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.
PMID: 30929895DERIVEDHusereau D, Feagan B, Selya-Hammer C. Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching. Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0.
PMID: 29411318DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BoYoung Choi / Clinical Operation Team Leader
- Organization
- Celltrion, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 26, 2014
Study Start
September 19, 2014
Primary Completion
January 11, 2016
Study Completion
February 15, 2017
Last Updated
May 9, 2018
Results First Posted
April 11, 2018
Record last verified: 2018-03