NIPH Clinical Trials Search

JRCT ID: jRCT2031230707

Registered date:15/03/2024

Single-arm, Open-label, Phase 3, Multi-center Study to Evaluate the Safety and Efficacy of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Crohns Disease in Japan

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCrohn Disease
Date of first enrollment01/04/2024
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)CT-P13 SC (Infliximab)


Primary OutcomeIncidence rate of grade 3 or higher TEAEs
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 75age old
Include criteria- Patient is Japanese male or female aged 18 to 75 years, inclusive. - Patient is in clinical remission defined as Crohns Disease Activity Index score of <150 points at Screening. - Patient who has been being treated with the standard dose of IV infliximab, for the treatment of CD for more than 6 months prior to the first administration of the study drug .
Exclude criteria- Patient who has previously received 2 or more biologic agents (except for infliximab), 2 or more Janus kinase (JAK) inhibitors, or 2 or more of both biologic agents and JAK inhibitors. - Patient who has previously received CT-P13 SC formulation

Related Information


Public contact
Name Kaneko Daiki
Address Sumitomo Fudousan Kayabacho Building. 3F, 1-16-3 Shinkawa, Chuo-ku, Tokyo, Japan Tokyo Japan 104-0033
Telephone +81-3-6260-6840
Affiliation Celltrion Healthcare Japan K.K
Scientific contact
Name Matsuoka Katsuyoshi
Address 564-1 Shimoshizu, Sakura, Chiba, Japan Chiba Japan 285-8741
Telephone +81-43-462-8811
Affiliation Toho university Sakura hospital