We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791842
First Posted: February 15, 2013
Last Update Posted: March 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
February 13, 2013
February 15, 2013
March 15, 2013
February 2013
May 2015   (Final data collection date for primary outcome measure)
serum CTX (type 1 collagen C-terminal breakdown product) [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01791842 on ClinicalTrials.gov Archive Site
  • Bone pain [ Time Frame: 6 months ]
    visual analog scale
  • serum ICTP (Carboxyterminal Telopeptide of Type I Collagen) [ Time Frame: 6 months ]
  • bone alkaline phosphatase [ Time Frame: 6 months ]
  • radiographs of mostly affected area [ Time Frame: 12 months ]
Same as current
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
Same as current
 
TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibrous Dysplasia of Bone
  • Drug: Tocilizumab
    8 mg/kg/month
  • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Tocilizumab
    • 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.
    Interventions:
    • Drug: Tocilizumab
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
12
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01791842
2010.648
2010-024282-41 ( EudraCT Number )
Yes
Not Provided
Not Provided
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP