Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722353
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2022-08-22
Brief Title:
IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIME
Brief Summary:
CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases IBD including Crohns disease and ulcerative colitis are chronic diseases characterized by relapsing and remitting episodes
About comparator strategiesprocedures Infliximab in its Intravenous IV form was the first biotherapy to be approved to treat IBD Biosimilars of intravenous IV infliximab have been shown to be non-inferior to the reference product in patients with IBD to induce and maintain clinical response
Recently the subcutaneous SC formulation of the infliximab biosimilar CT-P13 CT-P13 SC has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 CT-P13 IV These results were based on 66 patients treated with CT-P13 SC and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting
About comparator strategiesprocedures Infliximab in its Intravenous IV form was the first biotherapy to be approved to treat IBD Biosimilars of intravenous IV infliximab have been shown to be non-inferior to the reference product in patients with IBD to induce and maintain clinical response
Recently the subcutaneous SC formulation of the infliximab biosimilar CT-P13 CT-P13 SC has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 CT-P13 IV These results were based on 66 patients treated with CT-P13 SC and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting
Detailed Description:
The study assesses in real-life setting the IBD disease course of infliximab-naïve IBD patients treated with subcutaneous infliximab This study will look at the clinical and biological outcomes of people who take subcutaneous infliximab
The study will enroll approximately 120 participants with an indication for iv infliximab
All participants will receive 1 intravenous infusion on Day 1 and Week 2 followed by 1 SC injection on Week 6 and then 1 SC injection every 2 weeks for up to Week 48
Switch to subcutaneous infliximab Remsima SC at week 6 will be proposed as part of standard of care
This multi-center trial will be conducted in hospitals of Assistance Publique - Hôpitaux de Paris AP-HP The overall time to participate in this study is 48 weeks Participants will make approximately 5 visits to the clinic
The study will enroll approximately 120 participants with an indication for iv infliximab
All participants will receive 1 intravenous infusion on Day 1 and Week 2 followed by 1 SC injection on Week 6 and then 1 SC injection every 2 weeks for up to Week 48
Switch to subcutaneous infliximab Remsima SC at week 6 will be proposed as part of standard of care
This multi-center trial will be conducted in hospitals of Assistance Publique - Hôpitaux de Paris AP-HP The overall time to participate in this study is 48 weeks Participants will make approximately 5 visits to the clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01567-36 | OTHER | ANSM | None |