TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE

NCT ID: NCT01791842

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-05

Study Completion Date

2018-06-19

Brief Summary

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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

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Conditions

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Fibrous Dysplasia of Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tocilizumab first, then placebo

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

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

8 mg/kg/month

Placebo

Intervention Type DRUG

Placebo first, then Tocilizumab

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

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

8 mg/kg/month

Placebo

Intervention Type DRUG

Interventions

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Tocilizumab

8 mg/kg/month

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Rhumatologie, Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Service de rhumatologie, Hopital Edouard Herriot, HCL

Lyon, , France

Site Status

Service de rhumatologie, Hôpital Lariboisière

Paris, , France

Site Status

Countries

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France

References

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Chapurlat R, Gensburger D, Trolliet C, Rouanet S, Mehsen-Cetre N, Orcel P. Inhibition of IL-6 in the treatment of fibrous dysplasia of bone: The randomized double-blind placebo-controlled TOCIDYS trial. Bone. 2022 Apr;157:116343. doi: 10.1016/j.bone.2022.116343. Epub 2022 Jan 29.

Reference Type BACKGROUND
PMID: 35104665 (View on PubMed)

Related Links

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Other Identifiers

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2010-024282-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2010.648

Identifier Type: -

Identifier Source: org_study_id

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