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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03980639
Date of registration:	18/01/2019
Prospective Registration:	No
Primary sponsor:	University Hospital, Toulouse
Public title:	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
Scientific title:	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase
Date of first enrolment:	November 20, 2018
Target sample size:	594226
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03980639
Study type:	Observational
Study design:
Phase:

Countries of recruitment
France

Contacts

Name:	François MD MONTASTRUC, PhD
Address:
Telephone:	5 61 14 59 60
Email:	francois.montastruc@univ-tlse3.fr
Affiliation:

Name:	François MONTASTRUC, PhD MD
Address:
Telephone:	5 61 14 59 60
Email:	francois.montastruc@univ-tlse3.fr
Affiliation:

Name:	François MONTASTRUC, PhD MD
Address:
Telephone:
Email:
Affiliation:	University Hospital, Toulouse

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: patient treated with DMARD

Primary Outcome(s)

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]

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

Secondary Outcome(s)

Secondary ID(s)

RC31/18/0440

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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