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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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