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

Rheumatoid Arthritis Clinical Trial

— COGNOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291457
• Other study ID #: ML39114
• Status: Completed
• Start date: March 30, 2017
• Est. completion date: December 4, 2019

Study information

• Verified date: May 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	Onze Lieve Vrouwziekenhuis Aalst	Aalst
Belgium	Dr. Huppertz - Marx pgmbh	Amel
Belgium	Private Practice Els Van Essche	Bonheiden
Belgium	AZ Sint Jan	Brugge
Belgium	CHU St Pierre (César de Paepe)	Bruxelles
Belgium	Hospital Erasme	Bruxelles
Belgium	Rhumarc sciv sprl	Céroux-Mousty
Belgium	UZ Antwerpen	Edegem
Belgium	Rhumaconsult sciv sprl; Private Practice	Forchies-la-Marche
Belgium	Reumacentrum Genk	Genk
Belgium	Reumaclinic	Genk
Belgium	AZ Sint Lucas (Sint Lucas)	Gent
Belgium	GHdC Site Saint-Joseph	Gilly (Charleroi)
Belgium	CHC MontLégia	Liege
Belgium	CHU de Liège; Rhumatologie	Liège
Belgium	Heilig Hartziekenhuis vzw	Lier
Belgium	Private Practice; Reumatologie	Mechelen
Belgium	AZ Damiaan	Oostende
Belgium	AZ Alma vzw (Sijsele)	Sijsele
Belgium	AZ Turnhout Sint Jozef	Turnhout
Belgium	AZ Sint Jozef Malle	Westmalle

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

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