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

Withdrawn

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03109470
• Lead Sponsor: Pope Research Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-11
• Study First Submitted: 2013-11-13
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Biologic Treatment	2 years	To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study

Secondary Outcome Measures

Name	Time	Method
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
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)
Healthcare Utilization	2 years	To determine health-care utilization over 2 years after completion of the FUNCTION study
Work productivity	2 years	To determine work productivity over 2 years after 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.