Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

January 17, 2019 updated by: Bristol-Myers Squibb

An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being treated for rheumatoid arthritis in the US

Description

Inclusion Criteria:

  • Signed informed consent
  • Diagnosis of rheumatoid arthritis
  • > 18 years at index treatment initiation or switch
  • Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
  • Read/write English

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with rheumatoid arthritis initiating abatacept
Pts with RA initiating other biologic disease-modifying drugs
Pts w/ RA non-biologic disease-modifying anti-rheumatic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Key safety outcomes (targeted infections, malignancies, mortality)
Time Frame: Every 6 months throughout the study
Every 6 months throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-reported infusion reactions
Time Frame: Every 6 months throughout the study
Every 6 months throughout the study
Multiple sclerosis, lupus, and psoriasis
Time Frame: Every 6 months throughout the study
Every 6 months throughout the study
Adverse events in pregnant women who receive abatacept
Time Frame: Every 6 months throughout the study
Every 6 months throughout the study
Adverse events in subjects on abatacept who receive concomitant biologics
Time Frame: Every 6 months throughout the study
Every 6 months throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

National Data Bank for Rheumatic Diseases (NDB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2005

Primary Completion (Anticipated)

June 30, 2029

Study Completion (Anticipated)

June 30, 2029

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-045B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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