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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
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Sweden Using the ARTIS Register

Resource links provided by NLM:

Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 100000
Study Start Date: July 2008
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Residents of Sweden

Criteria

Inclusion Criteria:

  • Resident of Sweden

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094795

Sponsors and Collaborators
Bristol-Myers Squibb
Karolinska Institutet
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01094795     History of Changes
Other Study ID Numbers: IM101-125
Study First Received: March 24, 2010
Last Updated: February 17, 2012
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013