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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Polymyalgia Rheumatica

Treatments: Drug: Placebo; Drug: Tocilizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02908217

SEMAPHORE (RB15.210)

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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113 participants in 2 patient groups, including a placebo group

Tocilizumab

Experimental group

Description:

6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.

Treatment:

Drug: Tocilizumab

Placebo

Placebo Comparator group

Description:

6 Intravenous infusions of placebo (sterile sodium chloride solution) every 4 weeks

Treatment:

Drug: Placebo