Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696106
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-24
First Post:
2023-01-03
Brief Title:
Risk of Incident IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Risk of Incident Immune-mediated Inflammatory Diseases IMID in Patients Treated With Biologics and Immunosuppressive Drugs for a Single IMID
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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:
PROTECT-IMID
Brief Summary:
Individuals with immune-mediated inflammatory diseases IMIDs are at increased risk of developing other IMIDs possibly through shared pathogenic inflammatory pathways and up to 25 of patients with IMIDs have at least one other IMID Additionally a concomitant diagnosis of a second IMID is associated with a higher burden of disease which usually requires therapeutic escalation Thus this risk should be taken into account in the benefit-risk balance of IMIDs-related treatment While the risk of other major adverse events such as serious infection cancer and cardiovascular events have been assessed in patients exposed to immunosuppressive drugs and biologics the impact of these drugs on the risk of incident IMIDs remains largely unknown
The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID either inflammatory bowel disease inflammatory rheumatic diseases or cutaneous psoriasis
The main aim of this study is to assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID either inflammatory bowel disease inflammatory rheumatic diseases or cutaneous psoriasis
Detailed Description:
This is a retrospective cohort study including all patients identified with a first IMID between 2008 and 2020 based on the French administrative healthcare databases Système National des Données de Santé Index date will be the date of initiation of the first treatment of interest within the observation period
Primary objective
- To assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID either IBD inflammatory rheumatic diseases or cutaneous psoriasis
Secondary objectives
To describe the subtype of incident second IMIDs in patients starting biologics and immunosuppressive drugs for a first IMID and the related burden of disease
To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID according to each drug class
Conventional immunosuppressive drug including immunomodulators thiopurines and csDMARDs methotrexate
Anti-TNF infliximab adalimumab golimumab certolizumab etanercept
Biologics targeting the IL-12IL-23 pathways ustekinumab risankizumab guselkumab
Biologics targeting the IL-6 pathways tocilizumab sarilumab
Biologics targeting the IL-17 pathways secukinumab ixékizumab brodalumab
Biologics targeting cell adhesion anti-integrins vedolizumab
JAK inhibitors tofacitinib baricitinib upadacitinib
To assess the risk of an incident second IMID in patients with a first incident IMID after January 1st 2008 and starting biologics and immunosuppressive drugs for this IMID
To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID
By type of first IMID
By type of second IMID
Primary objective
- To assess the risk of an incident second IMID in patients starting biologics including anti-TNF and immunosuppressive drugs including small molecules for a first IMID either IBD inflammatory rheumatic diseases or cutaneous psoriasis
Secondary objectives
To describe the subtype of incident second IMIDs in patients starting biologics and immunosuppressive drugs for a first IMID and the related burden of disease
To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID according to each drug class
Conventional immunosuppressive drug including immunomodulators thiopurines and csDMARDs methotrexate
Anti-TNF infliximab adalimumab golimumab certolizumab etanercept
Biologics targeting the IL-12IL-23 pathways ustekinumab risankizumab guselkumab
Biologics targeting the IL-6 pathways tocilizumab sarilumab
Biologics targeting the IL-17 pathways secukinumab ixékizumab brodalumab
Biologics targeting cell adhesion anti-integrins vedolizumab
JAK inhibitors tofacitinib baricitinib upadacitinib
To assess the risk of an incident second IMID in patients with a first incident IMID after January 1st 2008 and starting biologics and immunosuppressive drugs for this IMID
To assess the risk of an incident second IMID in patients starting biologics and immunosuppressive drugs for a first IMID
By type of first IMID
By type of second IMID
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