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Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Data Bank for Rheumatic Diseases
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01088360
First received: March 12, 2010
Last updated: April 27, 2010
Last verified: April 2010
History of Changes

March 12, 2010
April 27, 2010
October 2006
January 2015   (final data collection date for primary outcome measure)
Key safety outcomes (targeted infections, malignancies, mortality) [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01088360 on ClinicalTrials.gov Archive Site
  • Patient-reported infusion reactions [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
  • Multiple sclerosis, lupus, and psoriasis [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
  • Adverse events in pregnant women who receive abatacept [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
  • Adverse events in subjects on abatacept who receive concomitant biologics [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)
An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients being treated for rheumatoid arthritis in the US
Rheumatoid Arthritis
Other: Observational Study
  • Patients with rheumatoid arthritis initiating abatacept
    Intervention: Other: Observational Study
  • Pts with RA initiating other biologic disease-modifying drugs
    Intervention: Other: Observational Study
  • Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs
    Intervention: Other: Observational Study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20000
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • Diagnosis of rheumatoid arthritis
  • > 18 years at index treatment initiation or switch
  • Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
  • Read/write English

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01088360
IM101-045B
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
National Data Bank for Rheumatic Diseases
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2010

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