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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03945019
Date of registration: 08/05/2019
Prospective Registration: Yes
Primary sponsor: Celltrion
Public title: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease
Scientific 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
Date of first enrolment: October 28, 2019
Target sample size: 600
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03945019
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Amit Gajera
Address: 
Telephone:
Email:
Affiliation: 
Name:     JeongWon Choi
Address: 
Telephone: +82 32 850 5773
Email: jeongwon.choi@celltrion.com
Affiliation: 
Key inclusion & exclusion 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 TNFa inhibitor or biological agent within
5 half-lives

- Patient who has previously demonstrated inadequate response or intolerance to TNFa
inhibitors for the treatment of CD.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: CT-P13 SC (Infliximab)
Other: Placebo SC
Primary Outcome(s)
Clinical remission [Time Frame: Week 54]
Secondary Outcome(s)
Secondary ID(s)
2019-001087-30
CT-P13 3.8
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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