Study Results
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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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2013-05-05
2018-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
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.
Tocilizumab
8 mg/kg/month
Placebo
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.
Tocilizumab
8 mg/kg/month
Placebo
Interventions
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Tocilizumab
8 mg/kg/month
Placebo
Eligibility Criteria
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Inclusion Criteria
* previously treated with IV bisphosphonates
* persistent bone pain and increased bone remodeling
Exclusion Criteria
* serious infectious diseases
* liver enzymes abnormality
* pregnancy
* dyslipidemia
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service de Rhumatologie, Groupe Hospitalier Pellegrin
Bordeaux, , France
Service de rhumatologie, Hopital Edouard Herriot, HCL
Lyon, , France
Service de rhumatologie, Hôpital Lariboisière
Paris, , France
Countries
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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.
Related Links
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Related Info
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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