NCT01094795

Brief Summary

The primary purpose of this study is to assess incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
92,635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

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

March 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

March 31, 2011

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

8.2 years

First QC Date

March 24, 2010

Last Update Submit

June 14, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Hospitalized infection

    Every 6 months throughout the study

  • Malignancy (total, lymphoma, lung cancer, breast cancer, colorectal cancer, prostate cancer)

    Every 6 months throughout the study

  • Total mortality

    Every 6 months throughout the study

Secondary Outcomes (1)

  • Autoimmune disorders (lupus, psoriasis, multiple sclerosis)

    Every 6 months throughout the study

Study Arms (5)

Patients initiating abatacept

Patients receiving other biologic disease-modifying drugs

Patients with early rheumatoid arthritis (RA)

Patients with prevalent RA identified by hospitalization

General population

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of Sweden

You may qualify if:

  • Resident of Sweden

You may not qualify if:

  • None

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

March 24, 2010

First Posted

March 29, 2010

Study Start

March 31, 2011

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

June 16, 2022

Record last verified: 2022-06