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Trial record 5 of 15 for:    "Fibrous dysplasia"
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TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

This study is currently recruiting participants.
Verified March 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01791842
First received: February 13, 2013
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Fibrous Dysplasia of Bone
 Drug: Tocilizumab
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    visual analog scale

  • serum ICTP (Carboxyterminal Telopeptide of Type I Collagen) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • bone alkaline phosphatase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • radiographs of mostly affected area [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Biological safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 12
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791842

Contacts
Contact: Roland CHAPURLAT, Professor +33472117481 roland.chapurlat@inserm.fr
Contact: Deborah GENSBURGER, Dr +33472119702 deborah.gensburger@chu-lyon.fr

Locations
France
Hopital Edouard Herriot - service de rhumatologie Recruiting
Lyon, France, 69003
Contact: Roland Chapurlat, Professor     +33472117481        
Principal Investigator: Roland CHAPURLAT, Professor            
Sub-Investigator: Deborah GENSBURGER, Dr            
Hôpital Lariboisière - service de rhumatologie Not yet recruiting
Paris, France, 75010
Contact: Philippe ORCEL, Professor            
Principal Investigator: Philippe ORCEL, Professor            
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01791842     History of Changes
Other Study ID Numbers: 2010.648, 2010-024282-41
Study First Received: February 13, 2013
Last Updated: March 14, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on June 18, 2013