Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis in Australia

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683604
• Other study ID #: ML28144
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: August 17, 2015
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Severe rheumatoid arthritis

• Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent

• Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

• RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit

• Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use

• Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra

• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra treatment		Approximately 2.5 years	No
Secondary	Rates of dose modifications/interruptions		Approximately 2.5 years	No
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		Approximately 2.5 years	No
Secondary	Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR		Approximately 2.5 years	No
Secondary	Efficacy: Proportion of patients on RoActemra/Actemra monotherapy		Approximately 2.5 years	No
Secondary	Laboratory parameters prior to and during infective adverse events and serious adverse events		Approximately 2.5 years	No
Secondary	Safety: Incidence of adverse events		Approximately 2.5 years	No
Secondary	Quality of life: HAQ-DI/VAS-Fatigue/FACIT-Fatigue/Patient Global Assessment of disease activity		Approximately 2.5 years	No