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Completed

NCT Number: NCT03696173

Safety Study of Abatacept in Rheumatoid Arthritis Participants

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2018
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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