NCT01247766

Brief Summary

The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 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

First Submitted

Initial submission to the registry

November 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 31, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

November 23, 2010

Last Update Submit

March 19, 2025

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Serious infection

    Every 2 years throughout the study

  • Incidence rates of malignancy

    (total, lymphoma, lung cancer, breast cancer, colorectal cancer)

    Every 2 years throughout the study

  • Total mortality

    Every 2 years throughout the study

Secondary Outcomes (1)

  • Multiple sclerosis

    Every 2 years throughout the study

Study Arms (3)

Patients with rheumatoid arthritis (RA) who receive abatacept

Patients with RA who receive BDM drugs

biologic disease-modifying (BDM)

Patients with RA who receive non-biologic DMARDs

disease-modifying anti-rheumatic drugs (DMARDs)

Eligibility Criteria

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

Residents of British Columbia who have received health care service for rheumatoid arthritis

You may qualify if:

  • Rheumatoid arthritis
  • Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
  • Age 18 years or older

You may not qualify if:

  • Below 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 24, 2010

Study Start

December 31, 2010

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

March 21, 2025

Record last verified: 2025-03