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Safety Study of Abatacept in Rheumatoid Arthritis Participants

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: NCT03696173
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Non-Interventional

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Study Type : Observational
Estimated Enrollment : 5800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study
Actual Study Start Date : December 17, 2015
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Participants taking abatacept Other: Non-Interventional
Non-Interventional

Participants taking abatacept with methotrexate Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Incidence of increased risk of serious infection while taking abatacept [ Time Frame: Approximately 7 years ]
    With methotrexate

  2. Incidence of malignancy while taking abatacept [ Time Frame: Approximately 7 years ]
    With methotrexate

  3. Incidence of increased risk of serious infection while taking abatacept [ Time Frame: Approximately 7 years ]
    Without methotrexate

  4. Incidence of malignancy while taking abatacept [ Time Frame: Approximately 7 years ]
    Without methotrexate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Rheumatoid arthritis (RA) participant, population-based cohort study approach within the US-based Truven MarketScan population and Supplemental US Medicare database
Criteria

Inclusion Criteria:

  • Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
  • Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
  • Patient is aged 18 years or older on the entry date
  • Patient was enrolled in the database for at least 180 days before the entry date

Exclusion Criteria:

  • Patient is younger than 18 years on the entry date
  • Patients who receive abatacept and another biologic simultaneously
  • Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome

Other protocol defined inclusion/exclusion criteria could apply


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): NCT03696173


Locations
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United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03696173     History of Changes
Other Study ID Numbers: IM101-605
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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