Clinical trial NCT03291457: A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
Official title: A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Week 52
measure: Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
timeFrame: Week 52
measure: Percentage of Participants by Reason for Glucocorticoid Dose Modification
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Glucocorticoid Dose
timeFrame: Baseline; Weeks 24 and 52
measure: Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
timeFrame: Weeks 24 and 52
measure: Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
timeFrame: Weeks 24 and 52
measure: Time to First Glucocorticoid Dose Reduction
timeFrame: Baseline up to Week 52
measure: Time to Glucocorticoid Discontinuation
timeFrame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction
timeFrame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
timeFrame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids
timeFrame: Baseline up to Week 52
measure: Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction
timeFrame: Baseline up to Week 52
measure: Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
timeFrame: Baseline up to Week 52
measure: Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids
timeFrame: Baseline up to Week 52
measure: Glucocorticoid Dose among Participants in Remission According to DAS28
timeFrame: Baseline up to Week 52
measure: Glucocorticoid Dose among Participants with LDA According to DAS28
timeFrame: Baseline up to Week 52
measure: Correlation between DAS28 Score and Glucocorticoid Dose
timeFrame: Baseline up to Week 52
measure: Percentage of Participants with Adverse Events
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Amel
country: Belgium
facility: Dr. Huppertz - Marx pgmbh
city: Bonheiden
country: Belgium
facility: Private Practice Els Van Essche
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Bruxelles
country: Belgium
facility: CHU St Pierre (César de Paepe)
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Céroux-Mousty
country: Belgium
facility: Rhumarc sciv sprl
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Forchies-la-Marche
country: Belgium
facility: Rhumaconsult sciv sprl; Private Practice
city: Genk
country: Belgium
facility: Reumacentrum Genk
city: Genk
country: Belgium
facility: Reumaclinic
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Gilly (Charleroi)
country: Belgium
facility: GHdC Site Saint-Joseph
city: Liege
country: Belgium
facility: CHC MontLégia
city: Lier
country: Belgium
facility: Heilig Hartziekenhuis vzw
city: Liège
country: Belgium
facility: CHU de Liège; Rhumatologie
city: Mechelen
country: Belgium
facility: Private Practice; Reumatologie
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Sijsele
country: Belgium
facility: AZ Alma vzw (Sijsele)
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Jozef
city: Westmalle
country: Belgium
facility: AZ Sint Jozef Malle
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: