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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03945019
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 4, 2021
Information provided by (Responsible Party):

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
Actual Study Start Date : October 28, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT03945019

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Contact: NaRae Ryu +82 32 850 5731
Contact: BoYoung Choi +82 32 850 5724

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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
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Responsible Party: Celltrion Identifier: NCT03945019    
Other Study ID Numbers: CT-P13 3.8
2019-001087-30 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021

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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
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents