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Trial record 3 of 13 for:    ct-p13

A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UC

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ClinicalTrials.gov Identifier: NCT02883452
Recruitment Status : Active, not recruiting
First Posted : August 30, 2016
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, PK and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active UC.

Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Biological: Infliximab Phase 1

Detailed Description:
A new subcutaneous infliximab formulation is being developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD or active UC.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Actual Study Start Date : September 12, 2016
Estimated Primary Completion Date : February 23, 2019
Estimated Study Completion Date : September 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CT-P13 IV
CT-P13 IV (Infliximab)
Biological: Infliximab
Experimental: CT-P13 SC
CT-P13 SC (Infliximab)
Biological: Infliximab



Primary Outcome Measures :
  1. To demonstrate that CT-P13 SC is noninferior to CT-P13 IV in terms of PK, as determined by the Ctrough (trough concentration, pre-dose level) at Week 22 [ Time Frame: Week 22 ]
    PK will be determined by the Ctrough



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

Inclusion Criteria:

  • Patient has a active Crohn's disease with a score on the Crohn's disease activity index score between 220 and 450 points.
  • Patient has a active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points.

Exclusion Criteria:

  • Patient who has previously received a biological agent for the treatment of CD and UC and/or a TNFα inhibitor for the treatment of other disease
  • Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product

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): NCT02883452


Locations
Korea, Republic of
Yeungnam University Hospital
Daegu, Korea, Republic of, 42415
Sponsors and Collaborators
Celltrion
Investigators
Study Chair: SuEun Song Celltrion

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02883452     History of Changes
Other Study ID Numbers: CT-P13 1.6 (SC)
2016-002124-89 ( EudraCT Number )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents