Safety Study of Abatacept in Sweden

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Karolinska Institutet

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01094795

First received: March 24, 2010

Last updated: February 17, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2010

Last Updated Date

February 17, 2012

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

October 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hospitalized infection [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer) [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
Total mortality [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01094795 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Autoimmune disorders (lupus, psoriasis, multiple sclerosis) [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of Abatacept in Sweden

Official Title ^ICMJE

A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register

Brief Summary

The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Residents of Sweden

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients initiating abatacept
Patients receiving other biologic disease-modifying drugs
Patients with early rheumatoid arthritis (RA)
Patients with prevalent RA identified by hospitalization
General population

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100000

Estimated Completion Date

October 2017

Estimated Primary Completion Date

October 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Resident of Sweden

Exclusion Criteria:

None

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01094795

Other Study ID Numbers ^ICMJE

IM101-125

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Karolinska Institutet

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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