NCT02169544

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

3.1 years

First QC Date

May 14, 2014

Last Update Submit

April 24, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (9)

  • Risk of Lung Cancer

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

    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)

  • Risk of lymphoma

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

    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)

  • Risk of breast cancer

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

    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)

  • Risk of non-melanoma skin cancer

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

    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)

  • Risk of all malignancies

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

    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)

  • Risk of hospitalized infections

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

    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)

  • Risk of pneumonia

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

    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)

  • Risk of opportunistic infections

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

    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)

  • Risk of tuberculosis

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

    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)

Secondary Outcomes (3)

  • Incidence of lupus

    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)

  • Incidence of multiple sclerosis

    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)

  • Incidence of psoriasis

    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)

Study Arms (2)

RA patients who are prescribed Abatacept

Abatacept

Drug: Abatacept

Patients who are prescribed other RA treatments

Interventions

AbataceptDRUG
RA patients who are prescribed Abatacept

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be selected from 4 US claims databases

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

June 23, 2014

Study Start

January 31, 2014

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04