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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:  NCT04205643
Date of registration: 18/12/2019
Prospective Registration: Yes
Primary sponsor: Celltrion
Public title: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis
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 Ulcerative Colitis
Date of first enrolment: September 2, 2020
Target sample size: 615
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04205643
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
Poland
Contacts
Name:     Jaroslaw Kierkus
Address: 
Telephone:
Email:
Affiliation: 
Name:     NaRae Ryu
Address: 
Telephone: +82 32 850 5769
Email: narae.ryu@celltrion.com
Affiliation: 
Key inclusion & exclusion 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 TNFa inhibitor or biologic agent within 5
half-lives



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
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)
2019-003849-15
CT-P13 3.7
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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