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

July 1, 2016 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with rheumatoid arthritis will be enrolled in this trial.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis participants
Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.
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.
Other Names:
  • RoActemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Activity Score Based on 28-joints Count (DAS28)
Time Frame: Month 12
Month 12
Simplified Disease Activity Index (SDAI) Score
Time Frame: Month 12
Month 12
Clinical Disease Activity Index (CDAI) Score
Time Frame: Month 12
Month 12
Percentage of Participants Achieving American College of Rheumatology (ACR) Response
Time Frame: Month 12
Month 12
Tender Joint Count (TJC)
Time Frame: Month 12
Month 12
Swollen Joint Count (SJC)
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with any Adverse Event (AE)
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 4, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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