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

November 1, 2016 updated by: Hoffmann-La Roche

A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.

This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

23

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

  • Spain
      • Alicante, Spain, 03700
      • Huesca, Spain, 22004
      • Leon, Spain, 24071
      • Salamanca, Spain, 37007
      • Valencia, Spain, 46340
      • Valencia, Spain, 46520
    • Alava
      • Vitoria, Alava, Spain, 01009
    • Alicante
      • Elche, Alicante, Spain, 03203
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
    • Leon
      • Ponferrada, Leon, Spain, 24411
    • Valencia
      • Alzira, Valencia, Spain, 46600
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids

Description

Inclusion Criteria:

  • Adults patients, over 18 years of age
  • Patients with moderate to severe rheumatoid arthritis (RA)
  • Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion

Exclusion Criteria:

  • Patients previously treated with RoActemra/Actemra
  • Any contraindication to RoActemra/Actemra

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
Time Frame: Week 36
Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glucocorticoid dose
Time Frame: Week 36
Week 36
Change from baseline in corticosteroid dose
Time Frame: Week 36
Week 36
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
Time Frame: Week 36
Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
Time Frame: Week 36
Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
Time Frame: Week 36
Week 36
Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day
Time Frame: Week 36
Week 36
Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day
Time Frame: Week 36
Week 36
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction
Time Frame: Week 36
Week 36
Percentage change in Disease Activity Score 28 (DAS28)
Time Frame: Week 36
Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score
Time Frame: Week 36
Week 36
Safety: Incidence of adverse events
Time Frame: 36 weeks
36 weeks

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

January 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML27904

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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