TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE (TOCIDYS)

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Civil Hospices of Lyon

Status and phase

Completed
Phase 2

Conditions

Fibrous Dysplasia of Bone

Treatments

Drug: Tocilizumab
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01791842
2010.648
2010-024282-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

19 participants in 2 patient groups

Tocilizumab first, then placebo
Experimental group
Description:
one IV infusion per month of Tocilizumab for 6 months followed by 1 infusion per month of placebo, for 6 months.
Treatment:
Drug: Placebo
Drug: Tocilizumab
Placebo first, then Tocilizumab
Experimental group
Description:
one IV infusion per month of Placebo for 6 months followed by 1 infusion per month of Tocilizumab, for 6 months.
Treatment:
Drug: Placebo
Drug: Tocilizumab

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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