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

Sponsor
Hoffmann-La Roche
Study ID
NCT03291457
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 30, 2017
Status verified
May 2020
Primary completion
Dec 4, 2019
Completion
Dec 4, 2019

Study Design

Enrollment
101 participants (actual)

Arms

  • Arm: Glucocorticoids + Tocilizumab
    Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.

Primary Outcome 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) [ Time Frame: Week 52 ]

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