NCT01088321

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
81,332

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

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

Study Start

First participant enrolled

March 1, 2005

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

11.7 years

First QC Date

March 12, 2010

Last Update Submit

December 7, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection

    Every four months throughout the study

Secondary Outcomes (3)

  • Anaphylactic reactions

    Every four months throughout the study

  • Multiple sclerosis, lupus, and psoriasis

    Every four months throughout the study

  • Concomitant biologic use

    Every four months throughout the study

Study Arms (3)

Patients initiating abatacept

Patients initiating other biologic disease-modifying drugs

Pts initiate non-biologic disease-modify anti-rheumatic drugs

Eligibility Criteria

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

United Healthcare

You may qualify if:

  • Diagnosis of rheumatoid arthritis
  • Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
  • Age 18 years or older at the time of drug initiation
  • Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

You may not qualify if:

  • Below 18 years of age at the time of BDM or DMARD initiation
  • Lacking six months of continuous enrollment prior to the initiation of one of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 12, 2010

First Posted

March 17, 2010

Study Start

March 1, 2005

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 8, 2016

Record last verified: 2016-12