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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: JPRN
Last refreshed on: 6 October 2020
Main ID:  JPRN-jRCT2031200117
Date of registration: 11/09/2020
Prospective Registration: No
Primary sponsor: Ishida Tetsuya
Public 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 Crohns 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 Crohns Disease
Date of first enrolment: 01/09/2020
Target sample size: 600
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCT2031200117
Study type:  Interventional
Study design:  randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose  
Phase:  3
Countries of recruitment
Austria Bulgaria Croatia Czech Republic France Germany Greece Hungary
Japan Latvia Poland Spain US
Contacts
Name: Tetsuya    Ishida
Address:  1-3-1, Higasi-omichi, Ohita 870-0823 Oita Japan
Telephone: +81-97-529-5777
Email: daiki.kaneko@celltrionhc.com
Affiliation:  Ishida IBD clinic
Name: Daiki    Kaneko
Address:  Sumitomo Fudousan Kayabacho Building. 3F, 1-16-3 Shinkawa, Chuo-ku, Tokyo, Japan 104-0033 Tokyo Japan
Telephone: +81-3-6260-6840
Email: daiki.kaneko@celltrionhc.com
Affiliation:  Celltrion Healthcare Japan K.K
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: >= 18age old
Age maximum: <= 75age old
Gender: Both
Health Condition(s) or Problem(s) studied
Crohns 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)
NCT03945019
Source(s) of Monetary Support
Secondary Sponsor(s)
Celltrion
Ethics review
Status: Approval
Approval date: 23/01/2020
Contact:
daiki.kaneko@celltrionhc.com
Jimbo Orthopedics Institutional Review Board
+81-3-6260-6840
daiki.kaneko@celltrionhc.com
Results
Results available:
Date Posted:
Date Completed:
URL:
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