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Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: March 12, 2010
Last updated: December 7, 2016
Last verified: December 2016
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 ]

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

Enrollment: 81332
Study Start Date: March 2005
Study Completion Date: November 2016
Primary Completion Date: November 2016 (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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01088321     History of Changes
Other Study ID Numbers: IM101-045A
Study First Received: March 12, 2010
Last Updated: December 7, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on July 19, 2017