Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Rheumatoid Arthritis Clinical Trial

Official title:

Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980639
• Other study ID #: RC31/18/0440
• Status: Recruiting
• Start date: November 20, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Toulouse
• Contact: François MONTASTRUC, PhD MD
• Phone: 5 61 14 59 60
• Email: francois.montastruc[@]univ-tlse3.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 investigator's study found in a US cohort of 64,000 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 594226
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• case reported in the World Health Organization (WHO) database of individual safety case report to 11/20/2018

• Patient treated with at least one bDMARD prescriptions

• adverse events reported were including the MedDRA terms

Exclusion Criteria:

• Chronology not compatible

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• patient treated with DMARD
Case report of cancer overall

Locations

Country	Name	City	State
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of reporting cancer overall specific cancers	Estimate statistically the risk of reporting cancer overall and specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis	Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018
Primary	Risk of reporting specific cancers	Estimate statistically the risk of specific cancers (including breast, lung, lymphoma, cervical, melanoma and NMSC) compared with all other adverse drug reactions (ADR) for abatacept compared to all ADRs for other bDMARDs performing a disproportionality analysis	Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018