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

JRCT ID: jRCT2031200117

Registered date:11/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Crohns Disease
• Date of first enrollment: 01/09/2020
• Target sample size: 600
• Countries of recruitment: US,Japan,Latvia,Japan,Czech Republic,Japan,France,Japan,Poland,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Spain,Japan,Austria,Japan,Bulgaria,Japan,Croatia,Japan
• Study type: Interventional

Intervention(s)

Biological: CT-P13 SC (Infliximab)
Other: Placebo SC

Outcome(s)

• Primary Outcome: Clinical remission [ Time Frame: Week 54 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ishida Tetsuya
• Secondary Sponsor: Celltrion
• Secondary ID(s): NCT03945019