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

Hoffmann-La Roche101 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

101

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabDRUG

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 AgentDRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

ASZ Aalst

Aalst, Belgium

Onze Lieve Vrouwziekenhuis Aalst

Aalst, Belgium

Outcomes

Primary Outcomes

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

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

Percentage of Participants by Reason for Glucocorticoid Dose Modification

Time frame: Baseline up to Week 52

Secondary Outcomes

Glucocorticoid Dose

Time frame: 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

Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%

Time frame: Weeks 24 and 52

Time to First Glucocorticoid Dose Reduction

Time frame: Baseline up to Week 52

Time to Glucocorticoid Discontinuation

Time frame: Baseline up to Week 52

Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction

Time frame: Baseline up to Week 52

Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.