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

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ClinicalTrials.gov Identifier: NCT03980639
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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 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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: patient treated with DMARD

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.

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Study Type : Observational
Estimated Enrollment : 594226 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
abatacept
patients with abatacept prescription
Drug: patient treated with DMARD
Case report of cancer overall

others bDMARDs
patients with at least one bDMARD prescriptions
Drug: patient treated with DMARD
Case report of cancer overall




Primary Outcome Measures :
  1. Risk of reporting cancer overall specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018 ]
    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

  2. Risk of reporting specific cancers [ Time Frame: Reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2018 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with one bDMARD
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980639


Contacts
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Contact: François MONTASTRUC, PhD MD 5 61 14 59 60 ext +33 francois.montastruc@univ-tlse3.fr

Locations
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France
UHToulouse Recruiting
Toulouse, France, 31059
Contact: François MD MONTASTRUC, PhD    5 61 14 59 60 ext +33    francois.montastruc@univ-tlse3.fr   
Contact: Isabelle OLIVIER, PhD    561777051 ext +33    olivier.i@chu-toulouse.FR   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Study Director: François MONTASTRUC, PhD MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03980639     History of Changes
Other Study ID Numbers: RC31/18/0440
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Abatacept
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents