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Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

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.
ClinicalTrials.gov Identifier: NCT01088360
Recruitment Status : Active, not recruiting
First Posted : March 17, 2010
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
National Data Bank for Rheumatic Diseases (NDB)
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 or disease
Rheumatoid Arthritis

Study Type : Observational
Estimated Enrollment : 20000 participants
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
Actual Study Start Date : March 31, 2005
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

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

Group/Cohort
Patients with rheumatoid arthritis initiating abatacept
Pts with RA initiating other biologic disease-modifying drugs
Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs



Primary Outcome Measures :
  1. Key safety outcomes (targeted infections, malignancies, mortality) [ Time Frame: Every 6 months throughout the study ]

Secondary Outcome Measures :
  1. Patient-reported infusion reactions [ Time Frame: Every 6 months throughout the study ]
  2. Multiple sclerosis, lupus, and psoriasis [ Time Frame: Every 6 months throughout the study ]
  3. Adverse events in pregnant women who receive abatacept [ Time Frame: Every 6 months throughout the study ]
  4. Adverse events in subjects on abatacept who receive concomitant biologics [ Time Frame: Every 6 months throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


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 ClinicalTrials.gov identifier (NCT number): NCT01088360


Sponsors and Collaborators
Bristol-Myers Squibb
National Data Bank for Rheumatic Diseases (NDB)
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01088360     History of Changes
Other Study ID Numbers: IM101-045B
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs