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Trial record 2 of 19 for:    CT-P13

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis

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.
 
ClinicalTrials.gov Identifier: NCT04205643
Recruitment Status : Not yet recruiting
First Posted : December 19, 2019
Last Update Posted : March 13, 2020
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 Ulcerative Colitis

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Biological: CT-P13 SC (Infliximab) Other: Placebo SC Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 615 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 Ulcerative Colitis
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

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 modified Mayo score which ranges from 0 to 9, including Stool frequency subscore, Rectal bleeding subscore and Endoscopic subscore but excluding Physician's global assessment subscore from the Total Mayo score.

    The Modified Mayo score will assess the participant's Stool frequency, Rectal bleeding and Endoscopic result and the higher Modified Mayo scores indicates worse outcome.




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 has moderately to severely active UC with a modified Mayo score of 5 to 9 points with endoscopic subscore of ≥ 2 points

Exclusion Criteria:

  • Patient who has previously received 2 or more biologic agents and/or JAK inhibitors
  • Patient who has previously received either a TNFα inhibitor or biologic agent within 5 half-lives

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): NCT04205643


Contacts
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Contact: NaRae Ryu +82 32 850 5769 narae.ryu@celltrion.com
Contact: BoYoung Choi +82 32 850 5735 boyoung.choi@celltrion.com

Sponsors and Collaborators
Celltrion
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04205643    
Other Study ID Numbers: CT-P13 3.7
2019-003849-15 ( EudraCT Number )
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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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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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents