A Non-Interventional Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

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: NCT01613378
• Other study ID #: ML28121
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: December 1, 2015
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

This multi-center, non-interventional study will evaluate the pattern of usage in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients initiated on treatment with RoActemra/Actemra according to the licensed Canadian product monograph recommendations will be followed for 12 months from the start of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe rheumatoid arthritis according to revised (1987) ACR criteria

• Initiated on RoActemra/Actemra treatment by the treating physician in accordance with the Canadian product monograph

• Informed consent to data being subject to computerized data processing

• Patient must fulfill the reimbursement criteria for treatment with RoActemra/Actemra under provincial or private health insurance coverage

Exclusion Criteria:

• Received RoActemra/Actemra prior to enrolment visit

• Previously received RoActemra/Actemra in a clinical trial or for compassionate use

• Enrolled in an ongoing clinical trial and/or received 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

• Participation in another clinical trial or industry sponsored observational study

• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis, with the exception of concomitant secondary Sjörgen's syndrome

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

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients on RoActemra/Actemra treatment at Month 6		approximately 21 months	No
Secondary	Percentage of patients on RoActemra/Actemra treatment at Month 12		approximately 21 months	No
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		approximately 21 months	No
Secondary	Rates of dose modifications/interruptions		approximately 21 months	No
Secondary	Change in total swollen and tender joint counts		from baseline to Month 12	No
Secondary	Change in disease activity score (DAS 28)		from baseline to Month 12	No
Secondary	Change in patient assessment of disease activity/pain/fatigue (VAS)		from baseline to Months 12	No
Secondary	Change in physician global assessment of disease activity (VAS)		from baseline to Month 12	No
Secondary	Change in duration of morning stiffness		from baseline to Month 12	No
Secondary	Change in C-reactive protein/ESR		from baseline to Month 12	No
Secondary	Percentage of patients achieving therapeutic response according to DAS28/EULAR/SDAI/CDAI criteria		approximately 21 months	No
Secondary	Use of concomitant medication (DMARDs, NSAIDs, corticosteroids)		approximately 21 months	No
Secondary	Efficacy: monotherapy versus combination therapy		approximately 21 months	No
Secondary	Safety: Incidence of adverse events		approximately 21 months	No
Secondary	Change in Quality of life: HAQ/MOS SF-36/Work Limitations Questionnaires		from baseline to Month 12	No