Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Rheumatoid Arthritis Clinical Trial

Official title:

Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809833
• Other study ID #: ML22734
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 20, 2016
• Start date: January 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich Institute
• Study type: Observational

Clinical Trial Summary

This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe RA

• Tocilizumab indicated in accordance with SmPC and chosen by the treating physician in advance of the study

Exclusion Criteria:

• None specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tocilizumab
Tocilizumab must be selected by the treating physician in advance of the study and will be not provided by the Sponsor. The dose/regimen are at the discretion of the prescriber.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Tocilizumab Regimens Prescribed in Compliance with SmPC		Baseline to end of treatment (up to 12 months)	No
Primary	Number of Tocilizumab Dose Adjustments		Baseline to end of treatment (up to 12 months)	No
Primary	Change from Baseline in 28-Joint Disease Activity Score (DAS28)		Baseline to end of treatment (up to 12 months)	No
Primary	Change from Baseline in Visual Analog Scale (VAS) Score of Physician-Assessed Disease Activity		Baseline to end of treatment (up to 12 months)	No
Secondary	Percentage of Participants Who Discontinue Treatment		Baseline to end of treatment (up to 12 months)	No
Secondary	Percentage of Participants with ADRs		Baseline to end of treatment (up to 12 months)	No