Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03980639
Status:
UNKNOWN
Last Update Posted:
2019-06-10
First Post:
2019-01-18
Brief Title:
Abatacept and the Risk of Cancer a Case Non-case Analysis in VigiBase
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Abatacept and the Risk of Cancer a Case Non-case Analysis in VigiBase
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
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:
None
Brief Summary:
There are very few data on the safety of Biologic Disease Modifying Anti-Rheumatic Drugs bDMARDs especially abatacept which compared to Tumor Necrosis Factor α TNFα inhibitors has distinct mechanism of action Abatacept is a recombinant fusion protein of human Cytotoxic T-Lymphocyte Antigen 4 CTLA-4 and the Fc region of human immunoglobulin gamma-1 IgG1 This CTLA4-fusion protein blocks the signal of T cell activation by binding to CD80 and CD86
Recently the investigators study found in a US cohort of 64000 patients with Rheumatoid Arthritis RA a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs article in press These results were in accordance with another prospective cohort study of the public health care system in Sweden showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors As these results warrant replication the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer including breast lung lymphoma cervical melanoma and NMSC compared to other bDMARDs
Recently the investigators study found in a US cohort of 64000 patients with Rheumatoid Arthritis RA a potential signal for a higher risk of cancer overall and particularly non-melanoma skin cancer with abatacept compared to other bDMARDs article in press These results were in accordance with another prospective cohort study of the public health care system in Sweden showing an increased risk of NMSC in abatacept users compared with TNFα inhibitors As these results warrant replication the present study will assess whether abatacept is associated with an increased risk of reporting overall cancer and specific cancer including breast lung lymphoma cervical melanoma and NMSC compared to other bDMARDs
Detailed Description:
A case non-case study using Vigibase the World Health Organization Global Individual Case Safety Reports ICSRs database which includes more than 18 million reports forwarded to the WHO Uppsala Monitoring Center by national pharmacovigilance systems from over 130 countries around the world since 1967 Information on the adverse effects reported include patient demographics and medical relevant history drugs recorded according to the WHO Drug dictionary and adverse drug reactions coded with Medical Dictionary for Regulatory Activities MedDRA terms will be perform
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