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Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis (TOCITAKA)

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.
 
ClinicalTrials.gov Identifier: NCT02101333
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and induction of remission in Takayasu arteritis (TA).

Condition or disease Intervention/treatment Phase
TAKAYASU ARTERITIS Drug: Tocilizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Tolerance of First-line Treatment With Tocilizumab in Active Takayasu Arteritis French Prospective Multicenter Study
Actual Study Start Date : June 10, 2014
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
Experimental: TOCILIZUMAB MONTHLY DURING 6
intravenous injection, 8 mg/kg, monthly during 6 months
Drug: Tocilizumab
intravenous injection 8 mg/kg, monthly during 6 months
Other Name: humanized anti-IL6 receptor antibody




Primary Outcome Measures :
  1. number of good responders without prednisone after 6-months tocilizumab treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of good and partial responders at 3 , 6, 12 months [ Time Frame: one year ]
  2. Total dose steroids during 6 months [ Time Frame: 6 months ]
    determined by the area under the curve

  3. TA global activity associated with tocilizumab treatment, by the questionnaires: BVAS, PGO, Dei-Tak; [ Time Frame: 18 months ]
  4. Clinical response evaluation [ Time Frame: 18 months ]
    Absence of new clinical features and stability or disappearance of baseline features

  5. Biological response evaluation [ Time Frame: 18 months ]
    Disappearance of inflammation or decrease of at least 50% (at least two parameters including VS, CRP, fibrinogen)

  6. radiological response : PET and MRI at 6, 9 and 12 months [ Time Frame: 12 months ]
  7. Patients quality of life associated with tocilizumab treatment, by the quality of life questionnaires: SF-36 [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of TA : ACR and /or Ishikawa modified Sharma criteria of TA
  • Age of 18 years or older
  • Willing to use an effective means of birth control throughout the study

Exclusion Criteria:

  • Patients immunosuppressive treatment or biologics other than steroids 4 months before
  • Evidence of active infection (including chronic infection)
  • HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen
  • History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
  • Inability to provide informed consent
  • Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)
  • Insufficient liver function
  • Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
  • Positive tuberculin skin test and/or positive Quantiferon
  • Radiographic evidence suggestive of tuberculosis
  • Contraindication to and precaution in use of Tocilizumab according to the summary product description
  • Pregnancy

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): NCT02101333


Locations
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France
Department of internal medicine
Saint-Antoine, Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Chugai Pharmaceutical
Investigators
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Principal Investigator: Olivier FAIN médecine interne - St Antoine
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02101333    
Other Study ID Numbers: P130404
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: July 2020
Keywords provided by Assistance Publique - Hôpitaux de Paris:
TAKAYASU ARTERITIS
STEROID SPARING
TOCILIZUMAB
EFFICACY
SAFETY
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases