TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

Phase 2

Completed

• Conditions: Fibrous Dysplasia of Bone
• Interventions: Drug: Tocilizumab; Drug: Placebo

• Registration Number: NCT01791842
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Study Start: 2013-05-05
• Primary Completion: 2015-05
• Study Completion: 2018-06-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tocilizumab first, then placebo	Placebo	one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Placebo first, then Tocilizumab	Placebo	one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Tocilizumab first, then placebo	Tocilizumab	one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Placebo first, then Tocilizumab	Tocilizumab	one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.

Primary Outcome Measures

Name	Time	Method
serum CTX (type 1 collagen C-terminal breakdown product)	6 months

Secondary Outcome Measures

Name	Time	Method
Bone pain	6 months	visual analog scale
bone alkaline phosphatase	6 months
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)	6 months
radiographs of mostly affected area	12 months

Trial Locations

Locations (3)

Service de Rhumatologie, Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Service de rhumatologie, Hopital Edouard Herriot, HCL; 🇫🇷 Lyon, France

Service de rhumatologie, Hôpital Lariboisière; 🇫🇷 Paris, France