NCT01088360

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Mar 2005

Longer than P75 for all trials

Status
active not recruiting

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 Progress87%
Mar 2005Jun 2029

Study Start

First participant enrolled

March 31, 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
19.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

24.3 years

First QC Date

March 12, 2010

Last Update Submit

January 17, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Key safety outcomes (targeted infections, malignancies, mortality)

    Every 6 months throughout the study

Secondary Outcomes (4)

  • Patient-reported infusion reactions

    Every 6 months throughout the study

  • Multiple sclerosis, lupus, and psoriasis

    Every 6 months throughout the study

  • Adverse events in pregnant women who receive abatacept

    Every 6 months throughout the study

  • Adverse events in subjects on abatacept who receive concomitant biologics

    Every 6 months throughout the study

Study Arms (3)

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

Eligibility Criteria

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

Patients being treated for rheumatoid arthritis in the US

You may qualify if:

  • 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

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 12, 2010

First Posted

March 17, 2010

Study Start

March 31, 2005

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

January 18, 2019

Record last verified: 2019-01