Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721004
• Other study ID #: ML22551
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: July 1, 2016
• Start date: March 2009
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion Criteria:

• No specific exclusion criteria were specified for this non-interventional trial

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tocilizumab
Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score Based on 28-joints Count (DAS28)		Month 12	No
Primary	Simplified Disease Activity Index (SDAI) Score		Month 12	No
Primary	Clinical Disease Activity Index (CDAI) Score		Month 12	No
Primary	Percentage of Participants Achieving American College of Rheumatology (ACR) Response		Month 12	No
Primary	Tender Joint Count (TJC)		Month 12	No
Primary	Swollen Joint Count (SJC)		Month 12	No
Secondary	Percentage of Participants with any Adverse Event (AE)		Up to 36 months	No