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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Glucocorticoid Agent; Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03291457

ML39114

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 1 patient group

Glucocorticoids + Tocilizumab

Description:

Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.

Treatment:

Drug: Tocilizumab

Drug: Glucocorticoid Agent