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TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

Primary Purpose

Fibrous Dysplasia of Bone

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tocilizumab
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrous Dysplasia of Bone focused on measuring fibrous dysplasia of bone, tocilizumab, McCune-Albright syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Rhumatologie, Groupe Hospitalier Pellegrin
  • Service de rhumatologie, Hopital Edouard Herriot, HCL
  • Service de rhumatologie, Hôpital Lariboisière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tocilizumab first, then placebo

Placebo first, then Tocilizumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum CTX (type 1 collagen C-terminal breakdown product)

Secondary Outcome Measures

Bone pain
visual analog scale
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
bone alkaline phosphatase
radiographs of mostly affected area

Full Information

First Posted
February 13, 2013
Last Updated
March 19, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01791842
Brief Title
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
Acronym
TOCIDYS
Official Title
TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2013 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrous Dysplasia of Bone
Keywords
fibrous dysplasia of bone, tocilizumab, McCune-Albright syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab first, then placebo
Arm Type
Experimental
Arm Description
one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Arm Title
Placebo first, then Tocilizumab
Arm Type
Experimental
Arm Description
one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
8 mg/kg/month
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
serum CTX (type 1 collagen C-terminal breakdown product)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bone pain
Description
visual analog scale
Time Frame
6 months
Title
serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
Time Frame
6 months
Title
bone alkaline phosphatase
Time Frame
6 months
Title
radiographs of mostly affected area
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Biological safety
Description
serum creatinine level, red blood cells, white blood cells, platelets, ASAT (Aspartate Amino Transferase), ALAT (Alanine Amino Transferase), CRP (C Reactive Protein) : each month cholesterol, triglycerides : before experimental treatment administration and at 8 weeks
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Rhumatologie, Groupe Hospitalier Pellegrin
City
Bordeaux
Country
France
Facility Name
Service de rhumatologie, Hopital Edouard Herriot, HCL
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Service de rhumatologie, Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.dysplasie-fibreuse-des-os.info
Description
Related Info

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