Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01338740
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2011-04-18
Brief Title:
Switching From Adalimumab to Infliximab
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohns Disease Patients With Primary Non-response or Loss of Response to Adalimumab
Status:
COMPLETED
Status Verified Date:
2023-01
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:
ADA-IFX
Brief Summary:
Switching to Adalimumab has proven to be efficacious in Crohns disease CD patients with intolerance or loss of response to Infliximab Currently there are no studies on the efficacy of switching to Infliximab in patients with loss of response or primary non-response to Adalimumab Even in rheumatology where switching between all classes of anti-TNFα biologicals is common practice there are no scientific data on switching from humanized to chimeric anti-TNFα antibodies
The purpose of this study is to document the efficacy of such a switch and to identify the possible predictive factors for success
If treatment with Adalimumab fails despite optimal dose and interval and the treating physician therefore decided to switch to infliximab the patient may be enrolled in this observational study At regular intervals every Remicade the patient will be clinically re-evaluated The disease activity score will be calculated Crohns disease activity index CDAI At regular intervals the results of interim blood tests will be documented 3x The succession will be 1 year At week 10 26 and 52 additional serum samples will be taken for determination of antibodies against Adalimumab and Infliximab The serum levels of Adalimumab week 0 and Infliximab week 10 26 and 52 will be determined
For this study there is no specific therapy change The study wants only to document the results of a therapy switch that in current clinical practice is made by the treating physician
The purpose of this study is to document the efficacy of such a switch and to identify the possible predictive factors for success
If treatment with Adalimumab fails despite optimal dose and interval and the treating physician therefore decided to switch to infliximab the patient may be enrolled in this observational study At regular intervals every Remicade the patient will be clinically re-evaluated The disease activity score will be calculated Crohns disease activity index CDAI At regular intervals the results of interim blood tests will be documented 3x The succession will be 1 year At week 10 26 and 52 additional serum samples will be taken for determination of antibodies against Adalimumab and Infliximab The serum levels of Adalimumab week 0 and Infliximab week 10 26 and 52 will be determined
For this study there is no specific therapy change The study wants only to document the results of a therapy switch that in current clinical practice is made by the treating physician
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None