NCT03109470

Brief Summary

Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2012

Status
withdrawn

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

November 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
Last Updated

April 13, 2017

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

November 13, 2013

Last Update Submit

April 12, 2017

Conditions

Rheumatoid Arthritis

Keywords

TocilizumabEarly Rheumatoid ArthritisObservationalCanadian

Outcome Measures

Primary Outcomes (1)

  • Rate of Biologic Treatment

    To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study

    2 years

Secondary Outcomes (5)

  • Treatment after completion of FUNCTION study

    Baseline

  • Rate of requiring treatment intensification

    2 years

  • Change in functional status

    2 years

  • Work productivity

    2 years

  • Healthcare Utilization

    2 years

Eligibility Criteria

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

Patients withdrawing first-line tocilizumab and/or methotrexate therapy due to therapeutic response during the FUNCTION (WA19926) study that have agreed to provide informed consent will be enrolled in this study.

You may qualify if:

  • Completed 2 years in the FUNCTION (WA19926) trial
  • Patient has provided written informed consent and is willing to comply with the requirements of this study protocol

You may not qualify if:

  • Requirement for immediate treatment with a biologic therapy following completion of the FUNCTION (WA19926) trial as per treating physician judgement.
  • Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA

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

  • Janet E Pope, MD, MPH, FRCPC

    Pope Research Corp.

    PRINCIPAL INVESTIGATOR

  • John S Sampalis, BSc, BA, MSc, PHD, FACE

    JSS Medical Research Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

November 13, 2013

First Posted

April 12, 2017

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 13, 2017

Record last verified: 2013-11