An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565122
• Other study ID #: ML28207
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: November 1, 2016
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2014
• Est. primary completion date: May 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

• Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria:

• RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B

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

• 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

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra treatment at 6 months		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: Monotherapy versus combination therapy		approximately 2.5 years	No
Secondary	Safety: Incidence of adverse events		approximately 2.5 years	No
Secondary	Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales		approximately 2.5 years	No