TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
TOCIDYS
TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
2 other identifiers
interventional
19
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2013
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedStudy Start
First participant enrolled
May 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2018
CompletedOctober 2, 2025
September 1, 2025
2 years
February 13, 2013
September 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum CTX (type 1 collagen C-terminal breakdown product)
6 months
Secondary Outcomes (4)
Bone pain
6 months
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
6 months
bone alkaline phosphatase
6 months
radiographs of mostly affected area
12 months
Other Outcomes (1)
Biological safety
12 months
Study Arms (2)
Tocilizumab first, then placebo
EXPERIMENTALone IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Placebo first, then Tocilizumab
EXPERIMENTALone IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- fibrous dysplasia of bone
- previously treated with IV bisphosphonates
- persistent bone pain and increased bone remodeling
You may not qualify if:
- Chronic renal failure
- serious infectious diseases
- liver enzymes abnormality
- pregnancy
- dyslipidemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Service de Rhumatologie, Groupe Hospitalier Pellegrin
Bordeaux, France
Service de rhumatologie, Hopital Edouard Herriot, HCL
Lyon, 69003, France
Service de rhumatologie, Hôpital Lariboisière
Paris, 75010, France
Related Publications (1)
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.
PMID: 35104665BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2013
First Posted
February 15, 2013
Study Start
May 5, 2013
Primary Completion
May 1, 2015
Study Completion
June 19, 2018
Last Updated
October 2, 2025
Record last verified: 2025-09