Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: March 12, 2010
Last updated: November 19, 2015
Last verified: November 2015
The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection [ Time Frame: Every four months throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anaphylactic reactions [ Time Frame: Every four months throughout the study ] [ Designated as safety issue: Yes ]
  • Multiple sclerosis, lupus, and psoriasis [ Time Frame: Every four months throughout the study ] [ Designated as safety issue: Yes ]
  • Concomitant biologic use [ Time Frame: Every four months throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40000
Study Start Date: March 2005
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Patients initiating abatacept
Patients initiating other biologic disease-modifying drugs
Pts initiate non-biologic disease-modify anti-rheumatic drugs


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

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis
  • Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
  • Age 18 years or older at the time of drug initiation
  • Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria:

  • Below 18 years of age at the time of BDM or DMARD initiation
  • Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01088321

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01088321     History of Changes
Other Study ID Numbers: IM101-045A 
Study First Received: March 12, 2010
Last Updated: November 19, 2015
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on February 09, 2016