The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03109470

Enrollment

Registered

2017-04-12

Start date

2012-11-30

Completion date

2014-11-30

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Tocilizumab, Early Rheumatoid Arthritis, Observational, Canadian

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Rate of Biologic Treatment	2 years	To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study

Secondary

Measure	Time frame	Description
Treatment after completion of FUNCTION study	Baseline	To determine the type of RA treatment regimen used by the treating physician upon completion of the FUNCTION study
Rate of requiring treatment intensification	2 years	To determine the rate of requiring treatment intensification with a traditional DMARD(s) completion of the FUNCTION study. The durability of response after completion of the FUNCTION study. The clinical measures of disease progression over 2 years after completion of the FUNCTION study. The clinical measures of disease progression over 2 years after completion of the FUNCTION study.
Change in functional status	2 years	The change in patient-reported functional status over 2 years after tocilizumab withdrawal or maintaining Mtx or changing DMARD(s)
Work productivity	2 years	To determine work productivity over 2 years after completion of the FUNCTION study
Healthcare Utilization	2 years	To determine health-care utilization over 2 years after completion of the FUNCTION study

Outcome results