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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
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
 Other: Observational Study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

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:
  • Key safety outcomes (targeted infections, malignancies, mortality) [ Time Frame: Every 6 months throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20000
Study Start Date: October 2006
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with rheumatoid arthritis initiating abatacept Other: Observational Study
Pts with RA initiating other biologic disease-modifying drugs Other: Observational Study
Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs Other: Observational Study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients being treated for rheumatoid arthritis in the US

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088360

Sponsors and Collaborators
Bristol-Myers Squibb
National Data Bank for Rheumatic Diseases
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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01088360     History of Changes
Other Study ID Numbers: IM101-045B
Study First Received: March 12, 2010
Last Updated: April 27, 2010
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
 Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013