A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice (COGNOS)

May 14, 2020 updated by: Hoffmann-La Roche

A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

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

  • Belgium
      • Aalst, Belgium, 9300
        • Onze Lieve Vrouwziekenhuis Aalst
      • Aalst, Belgium, 9300
        • ASZ Aalst
      • Amel, Belgium, 4770
        • Dr. Huppertz - Marx pgmbh
      • Bonheiden, Belgium, 2820
        • Private Practice Els Van Essche
      • Brugge, Belgium, 8000
        • AZ Sint Jan
      • Bruxelles, Belgium, 1070
        • Hospital Erasme
      • Bruxelles, Belgium, 1000
        • CHU St Pierre (César de Paepe)
      • Céroux-Mousty, Belgium, 1341
        • Rhumarc sciv sprl
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Forchies-la-Marche, Belgium, 6141
        • Rhumaconsult sciv sprl; Private Practice
      • Genk, Belgium, 3600
        • ReumaClinic
      • Genk, Belgium, 3600
        • Reumacentrum Genk
      • Gent, Belgium, 9000
        • AZ Sint Lucas (Sint Lucas)
      • Gilly (Charleroi), Belgium, 6000
        • GHdC Site Saint-Joseph
      • Liege, Belgium, 4000
        • CHC MontLegia
      • Lier, Belgium, 2500
        • Heilig Hartziekenhuis vzw
      • Liège, Belgium, 4000
        • CHU de Liège; Rhumatologie
      • Mechelen, Belgium, 2800
        • Private Practice; Reumatologie
      • Oostende, Belgium, 8400
        • AZ Damiaan
      • Sijsele, Belgium, 8340
        • AZ Alma vzw (Sijsele)
      • Turnhout, Belgium, 2300
        • AZ Turnhout Sint Jozef
      • Westmalle, Belgium, 2390
        • AZ Sint Jozef Malle

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

Non-Probability Sample

Study Population

This study will follow participants with RA who are receiving glucocorticoids prior to start of tocilizumab in daily clinical practice.

Description

Inclusion Criteria:

  • Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
  • Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
  • Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
  • Treated with glucocorticoids for RA when starting tocilizumab treatment

Exclusion Criteria:

  • Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
  • Continuous or regular treatment with oral corticosteroids for any indication other than RA

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glucocorticoids + Tocilizumab
Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
Drug: Tocilizumab
For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
Other Names:
  • RoActemra
Drug: Glucocorticoid Agent
Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)
Time Frame: Week 52
Week 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
Time Frame: Week 52
Week 52
Percentage of Participants by Reason for Glucocorticoid Dose Modification
Time Frame: Baseline up to Week 52
Baseline up to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucocorticoid Dose
Time Frame: Baseline; Weeks 24 and 52
Baseline; Weeks 24 and 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
Time Frame: Weeks 24 and 52
Weeks 24 and 52
Time to First Glucocorticoid Dose Reduction
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Time to Glucocorticoid Discontinuation
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Glucocorticoid Dose among Participants in Remission According to DAS28
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Glucocorticoid Dose among Participants with LDA According to DAS28
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Correlation between DAS28 Score and Glucocorticoid Dose
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Percentage of Participants with Adverse Events
Time Frame: Baseline up to Week 52
Baseline up to Week 52

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 (Actual)

March 30, 2017

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

December 4, 2019

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39114

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Tocilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe