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Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01088321
First received: March 12, 2010
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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
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:

Drug Information available for: Abatacept
U.S. FDA Resources

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: June 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients initiating abatacept
Patients initiating other biologic disease-modifying drugs
Pts initiate non-biologic disease-modify anti-rheumatic drugs

  Eligibility

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

United Healthcare

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088321

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01088321     History of Changes
Other Study ID Numbers: IM101-045A
Study First Received: March 12, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013