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

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ClinicalTrials.gov Identifier: NCT02169544
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Abatacept

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Study Type : Observational
Actual Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-marketing Study Assessing the Long-Term Safety of Abatacept
Actual Study Start Date : January 31, 2014
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
RA patients who are prescribed Abatacept
Abatacept
Drug: Abatacept
Patients who are prescribed other RA treatments



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Patients will be selected from 4 US claims databases
Criteria

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

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): NCT02169544


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: NCT02169544     History of Changes
Other Study ID Numbers: IM101-488
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents