A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
COGNOS
A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
1 other identifier
observational
101
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2017
CompletedFirst Submitted
Initial submission to the registry
September 20, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2019
CompletedMay 18, 2020
May 1, 2020
2.7 years
September 20, 2017
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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
Week 52
Percentage of Participants by Reason for Glucocorticoid Dose Modification
Baseline up to Week 52
Secondary Outcomes (15)
Glucocorticoid Dose
Baseline; Weeks 24 and 52
Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
Weeks 24 and 52
Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
Weeks 24 and 52
Time to First Glucocorticoid Dose Reduction
Baseline up to Week 52
Time to Glucocorticoid Discontinuation
Baseline up to Week 52
- +10 more secondary outcomes
Study Arms (1)
Glucocorticoids + Tocilizumab
Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
Interventions
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.
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.
Eligibility Criteria
This study will follow participants with RA who are receiving glucocorticoids prior to start of tocilizumab in daily clinical practice.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
ASZ Aalst
Aalst, 9300, Belgium
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300, Belgium
Dr. Huppertz - Marx pgmbh
Amel, 4770, Belgium
Private Practice Els Van Essche
Bonheiden, 2820, Belgium
AZ Sint Jan
Bruges, 8000, Belgium
CHU St Pierre (César de Paepe)
Brussels, 1000, Belgium
Hospital Erasme
Brussels, 1070, Belgium
Rhumarc sciv sprl
Céroux-Mousty, 1341, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Rhumaconsult sciv sprl; Private Practice
Forchies-la-Marche, 6141, Belgium
Reumacentrum Genk
Genk, 3600, Belgium
Reumaclinic
Genk, 3600, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
GHdC Site Saint-Joseph
Gilly (Charleroi), 6000, Belgium
Heilig Hartziekenhuis vzw
Lier, 2500, Belgium
CHC MontLégia
Liège, 4000, Belgium
CHU de Liège; Rhumatologie
Liège, 4000, Belgium
Private Practice; Reumatologie
Mechelen, 2800, Belgium
AZ Damiaan
Ostend, 8400, Belgium
AZ Alma vzw (Sijsele)
Sijsele, 8340, Belgium
AZ Turnhout Sint Jozef
Turnhout, 2300, Belgium
AZ Sint Jozef Malle
Westmalle, 2390, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2017
First Posted
September 25, 2017
Study Start
March 30, 2017
Primary Completion
December 4, 2019
Study Completion
December 4, 2019
Last Updated
May 18, 2020
Record last verified: 2020-05