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Safety Study of Abatacept in Sweden

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01094795
Recruitment Status : Active, not recruiting
First Posted : March 29, 2010
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Estimated Enrollment : 100000 participants
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
Actual Study Start Date : March 31, 2011
Estimated Primary Completion Date : June 24, 2019
Estimated Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort
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



Primary Outcome Measures :
  1. Hospitalized infection [ Time Frame: Every 6 months throughout the study ]
  2. Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer) [ Time Frame: Every 6 months throughout the study ]
  3. Total mortality [ Time Frame: Every 6 months throughout the study ]

Secondary Outcome Measures :
  1. Autoimmune disorders (lupus, psoriasis, multiple sclerosis) [ Time Frame: Every 6 months throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Residents of Sweden
Criteria

Inclusion Criteria:

  • Resident of Sweden

Exclusion Criteria:

  • None

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): NCT01094795


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

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01094795     History of Changes
Other Study ID Numbers: IM101-125
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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