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TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

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ClinicalTrials.gov Identifier: NCT01791842
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fibrous Dysplasia of Bone Drug: Tocilizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
Actual Study Start Date : May 5, 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 19, 2018


Arm Intervention/treatment
Experimental: 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.
Drug: Tocilizumab
8 mg/kg/month

Drug: Placebo
Experimental: 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.
Drug: Tocilizumab
8 mg/kg/month

Drug: Placebo



Primary Outcome Measures :
  1. serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Bone pain [ Time Frame: 6 months ]
    visual analog scale

  2. serum ICTP (Carboxyterminal Telopeptide of Type I Collagen) [ Time Frame: 6 months ]
  3. bone alkaline phosphatase [ Time Frame: 6 months ]
  4. radiographs of mostly affected area [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Biological safety [ Time Frame: 12 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791842


Locations
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France
Service de Rhumatologie, Groupe Hospitalier Pellegrin
Bordeaux, France
Service de rhumatologie, Hopital Edouard Herriot, HCL
Lyon, France, 69003
Service de rhumatologie, Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Hospices Civils de Lyon

Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01791842     History of Changes
Other Study ID Numbers: 2010.648
2010-024282-41 ( EudraCT Number )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

Keywords provided by Hospices Civils de Lyon:
fibrous dysplasia of bone
tocilizumab
McCune-Albright syndrome

Additional relevant MeSH terms:
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Hyperplasia
Fibrous Dysplasia of Bone
Pathologic Processes
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases