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Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

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. Identifier: NCT01088321
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 81332 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
Study Start Date : March 2005
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Patients initiating abatacept
Patients initiating other biologic disease-modifying drugs
Pts initiate non-biologic disease-modify anti-rheumatic drugs

Primary Outcome Measures :
  1. 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 :
  1. Anaphylactic reactions [ Time Frame: Every four months throughout the study ]
  2. Multiple sclerosis, lupus, and psoriasis [ Time Frame: Every four months throughout the study ]
  3. Concomitant biologic use [ Time Frame: Every four months throughout the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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
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

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 identifier (NCT number): NCT01088321

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

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Responsible Party: Bristol-Myers Squibb Identifier: NCT01088321     History of Changes
Other Study ID Numbers: IM101-045A
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Connective Tissue Diseases
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors