Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease

• ClinicalTrials.gov Identifier: NCT02096861
• Recruitment Status: Completed
• First Posted: March 26, 2014
• Results First Posted: April 11, 2018
• Last Update Posted: May 9, 2018
• Sponsor: Celltrion
• Collaborator: Pfizer
• Information provided by (Responsible Party): Celltrion

Tracking Information

• First Submitted Date: March 24, 2014
• First Posted Date: March 26, 2014
• Results First Submitted Date: February 14, 2018
• Results First Posted Date: April 11, 2018
• Last Update Posted Date: May 9, 2018
• Actual Study Start Date: September 19, 2014
• Actual Primary Completion Date: January 11, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 10, 2018)

The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: March 24, 2014): Efficacy evaluated by Assessment of Crohn's disease activity index -70 response [ Time Frame: at Week 6 ]

Current Secondary Outcome Measures (submitted: April 10, 2018)

• The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 [ Time Frame: Week 30 ]
  A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
• The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54 [ Time Frame: Week 54 ]
  A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
• The Number and Percentage of Patients Achieving Clinical Remission at Week 6 [ Time Frame: Week 6 ]
  Clinical remission was defined as an absolute CDAI score of less than 150 points.
• The Number and Percentage of Patients Achieving Clinical Remission at Week 30 [ Time Frame: Week 30 ]
  Clinical remission was defined as an absolute CDAI score of less than 150 points.
• The Number and Percentage of Patients Achieving Clinical Remission at Week 54 [ Time Frame: Week 54 ]
  Clinical remission was defined as an absolute CDAI score of less than 150 points.
• The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Up to Week 30 ]
  SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.
• The Short Inflammatory Bowel Disease Questionnaire [ Time Frame: Baseline and Week 54 ]
  SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70. Higher values of SIBDQ represent a better patient disease outcome.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
• Official Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Crohn's Disease

Intervention

• Biological: CT-P13
  CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
• Biological: Remicade
  Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

Study Arms

• Experimental: CT-P13 - CT-P13
  CT-P13 followed by CT-P13 from Week 30
  Intervention: Biological: CT-P13
• Active Comparator: CT-P13 - Remicade
  CT-P13 followed by Remicade from Week 30
  Interventions:

  • Biological: CT-P13
  • Biological: Remicade
• Active Comparator: Remicade - Remicade
  Remicade followed by Remicade from Week 30
  Intervention: Biological: Remicade
• Experimental: Remicade - CT-P13
  Remicade followed by CT-P13 from Week 30
  Interventions:

  • Biological: CT-P13
  • Biological: Remicade

Publications *

• 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.
• Dulai 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.
• Wong 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.
• Ye 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.
• Husereau 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 11, 2016): 220
• Original Estimated Enrollment (submitted: March 24, 2014): 214
• Actual Study Completion Date: February 15, 2017
• Actual Primary Completion Date: January 11, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02096861
• Other Study ID Numbers: CT-P13 3.4; 2013-004497-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Celltrion
• Original Responsible Party: Same as current
• Current Study Sponsor: Celltrion
• Original Study Sponsor: Same as current
• Collaborators: Pfizer
• Investigators: Not Provided
• PRS Account: Celltrion
• Verification Date: March 2018