TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

Civil Hospices of Lyon

Status and phase: Completed; Phase 2

Conditions: Fibrous Dysplasia of Bone

Treatments: Drug: Placebo; Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01791842

2010.648

2010-024282-41 (EudraCT Number)

Details and patient eligibility

About

Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fibrous dysplasia of bone
• previously treated with IV bisphosphonates
• persistent bone pain and increased bone remodeling

Exclusion criteria

• Chronic renal failure
• serious infectious diseases
• liver enzymes abnormality
• pregnancy
• dyslipidemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups

Tocilizumab first, then placebo

Experimental group

Description:

one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.

Treatment:

Drug: Tocilizumab

Drug: Placebo

Placebo first, then Tocilizumab

Experimental group

Description:

one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.

Treatment:

Drug: Tocilizumab

Drug: Placebo