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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03109470
• Other study ID #: PRC-03-2012
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2013
• Last updated: April 12, 2017
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2013
• Source: Pope Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pope Research Corporation	Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Biologic Treatment	To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study	2 years
Secondary	Treatment after completion of FUNCTION study	To determine the type of RA treatment regimen used by the treating physician upon completion of the FUNCTION study	Baseline
Secondary	Rate of requiring treatment intensification	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.	2 years
Secondary	Change in functional status	The change in patient-reported functional status over 2 years after tocilizumab withdrawal or maintaining Mtx or changing DMARD(s)	2 years
Secondary	Work productivity	To determine work productivity over 2 years after completion of the FUNCTION study	2 years
Secondary	Healthcare Utilization	To determine health-care utilization over 2 years after completion of the FUNCTION study	2 years