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CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03945019
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

Condition or disease Intervention/treatment Phase
Crohn's Disease Biological: CT-P13 SC (Infliximab) Other: Placebo SC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: CT-P13 SC Biological: CT-P13 SC (Infliximab)
Subcutaneous injection of CT-P13 SC

Placebo Comparator: Placebo SC Other: Placebo SC
Subcutaneous injection of Placebo SC




Primary Outcome Measures :
  1. Clinical remission [ Time Frame: Week 54 ]
    Clinical remission defined by CDAI score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female aged 18 to 75 years, inclusive.
  • Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Exclusion Criteria:

  • Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
  • Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945019


Contacts
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Contact: MiSun Lee +82 32 850 5738 misun.lee@celltrion.com
Contact: BoYoung Choi +82 32 850 5735 boyoung.choi@celltrion.com

Locations
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United States, Ohio
GC GA DBA Consultants for Clinical Research Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Amit Gajera         
Sponsors and Collaborators
Celltrion

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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03945019     History of Changes
Other Study ID Numbers: CT-P13 3.8
2019-001087-30 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents