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Completed

NCT Number: NCT02169544

Post-marketing Study Assessing the Long-Term Safety of Abatacept

The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.

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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

Who can participate

Healthy volunteers accepted: No

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Patient has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
  • Patient is aged 18 years or older on the index date
  • Patient was enrolled in the database for at least 180 days before the index date
  • Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment

Treatment and study plan

Abatacept

Drug

Primary outcomes

  1. Risk of Lung Cancer

    Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  2. Risk of lymphoma

    Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  3. Risk of breast cancer

    Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  4. Risk of non-melanoma skin cancer

    Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  5. Risk of all malignancies

    Time frame: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  6. Risk of hospitalized infections

    Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  7. Risk of pneumonia

    Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  8. Risk of opportunistic infections

    Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

  9. Risk of tuberculosis

    Time frame: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)

    The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug

Secondary outcomes

  1. Incidence of lupus

    Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept

  2. Incidence of multiple sclerosis

    Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept

  3. Incidence of psoriasis

    Time frame: Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)

    The index date is defined as the date that the patient initiates Abatacept

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2014
Registry last updated
Apr 25, 2017

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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