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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Tocilizumab; Drug: Glucocorticoid Agent

• Registration Number: NCT03291457
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glucocorticoids + Tocilizumab	Glucocorticoid Agent	Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
Glucocorticoids + Tocilizumab	Tocilizumab	Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (22)

Private Practice Els Van Essche; 🇧🇪 Bonheiden, Belgium

Rhumarc sciv sprl; 🇧🇪 Céroux-Mousty, Belgium

CHC MontLégia; 🇧🇪 Liege, Belgium

Private Practice; Reumatologie; 🇧🇪 Mechelen, Belgium

Onze Lieve Vrouwziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Dr. Huppertz - Marx pgmbh; 🇧🇪 Amel, Belgium

CHU St Pierre (César de Paepe); 🇧🇪 Bruxelles, Belgium

Hospital Erasme; 🇧🇪 Bruxelles, Belgium

GHdC Site Saint-Joseph; 🇧🇪 Gilly (Charleroi), Belgium

Reumacentrum Genk; 🇧🇪 Genk, Belgium

AZ Sint Lucas (Sint Lucas); 🇧🇪 Gent, Belgium

Heilig Hartziekenhuis vzw; 🇧🇪 Lier, Belgium

AZ Damiaan; 🇧🇪 Oostende, Belgium

AZ Turnhout Sint Jozef; 🇧🇪 Turnhout, Belgium

AZ Sint Jozef Malle; 🇧🇪 Westmalle, Belgium

AZ Sint Jan; 🇧🇪 Brugge, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

Reumaclinic; 🇧🇪 Genk, Belgium

CHU de Liège; Rhumatologie; 🇧🇪 Liège, Belgium

AZ Alma vzw (Sijsele); 🇧🇪 Sijsele, Belgium

UZ Antwerpen; 🇧🇪 Edegem, Belgium

Rhumaconsult sciv sprl; Private Practice; 🇧🇪 Forchies-la-Marche, Belgium