Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

Summary

Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborator: Roche Chugai
• Treatments: Glucocorticoids

Criteria

Inclusion Criteria:

• Age older than 50 years

• Fulfilled the Chuang criteria

• And currently:

• PMR-AS> 10

• Absence of signs or symptoms of other musculoskeletal or connective tissue conditions

• Able to give informed consent

• Concomitant treatments with methotrexate or hydroxy-chloroquine are permitted if stable dose since 3 months.

Exclusion Criteria:

• Clinical symptoms of giant cell arteritis

• Uncontrolled dyslipidemia, high blood pressure or cardiovascular disease

• History of major organ or haematopoietic stem cell/marrow transplant

• Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR

• Planned surgical procedure within 12 months after randomization.

• History of malignant neoplasm within the last 5 years.

• Current active infection

• Patient with elevated ALT or AST> 5 ULN