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Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. (HORTOCI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01910038
First Posted: July 29, 2013
Last Update Posted: November 30, 2017
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):
Centre Hospitalier Universitaire Dijon
  Purpose
It has been reported that around 40% of GCA patients are able to decrease the prednisone dose until 0.1 mg/Kg/d or less after 6 months of treatment. In this study, we hypothesized that adding 3 months of tocilizumab to prednisone could increase the percentage from 40 to 70%.

Condition Intervention Phase
Giant Cell Arteritis Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day [ Time Frame: Week 26 ]

    Remission: absence of symptoms attributable to Giant Cell Arteritis and normalization of inflammatory markers (CRP<10 mg/L and ESR<30 mm/h).

    Relapse: recurrence of symptoms attributable to active GCA and/or increased levels of inflammatory markers (CRP≥10 mg/L and/or ESR≥30 mm/h). Elevation of inflammatory markers in the absence of GCA symptoms was considered relapse if it persisted at two time points at 1 week apart without any other obvious etiology than GCA.



Secondary Outcome Measures:
  • Frequency and type of adverse effects encountered [ Time Frame: Until Week 52 ]
  • Percentage of relapses [ Time Frame: Week 26 and Week 52 ]
  • Time to the first relapse [ Time Frame: Until Week 52 ]
  • Factors associated with the occurrence of relapse [ Time Frame: Until Week 52 ]
  • The cumulative dose of prednisone. [ Time Frame: Weeks 26 and 52 ]

Enrollment: 20
Actual Study Start Date: November 8, 2013
Study Completion Date: June 13, 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone+Tocilizumab
Prednisone (0.7 mg/Kg/d and then progressively tapered to reach 0.1 mg/Kg/d at W24) + tocilizumab 8mg/Kg/4 weeks for a total of 4 infusions (S0, S4, S8, S12).
Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 50 years
  • GCA fulfilling ≥3/5 ACR criteria
  • Newly diagnosed GCA or relapsing GCA if treatments (Glucocorticoids±immunosuppressants) have been stopped for at least 6 months
  • Glucocorticoids started for less than 21 days
  • Proof of large vessel vasculitis:

    • Positive temporal artery biopsy (TAB)
    • Aortitis, as defined by regular circumferential wall thickening ≥3mm in the absence of calcification and/or significant atheroma on angio-CT images; or a homogeneous vascular signal more intense than the liver on 18FDG-PET images.
  • For men and women of a child-bearing age, an effective method of contraception must be used by the patient or his or her partner throughout the treatment with tocilizumab (or placebo) and for 3 months after the end of the treatment. Breast-feeding is not authorised until 3 months after the end of treatment with tocilizumab. Women not considered at risk of pregnancy are those defined by menopause of at least one year or surgically steriles (ligature of the fallopian tubes, bilateral ovariectomy or hysterectomy)
  • Persons who have provided written informed consent
  • Persons covered by the National Health Insurance Agency

Exclusion Criteria:

  • Pregnancy
  • hospitalization in the previous year for drug or alcohol intoxication
  • current treatment for another autoimmune or inflammatory disease
  • known hypersensitivity to TCZ or one of its excipients or another human or murine monoclonal antibody
  • treatment with anti-TNF-α, methotrexate, cyclophosphamide, dapsone, methylprednisolone pulses or any other immunosuppressive or immunomodulatory drug or biotherapy within 6 months before inclusion
  • long-course systemic GC therapy
  • prednisone therapy >1 mg/kg/day, whatever the duration
  • serious or chronic proven infections requiring hospitalization or intravenous antibiotics within 30 days before inclusion
  • other proven infections that required antibiotics within 14 days before inclusion
  • opportunistic infections
  • evidence of active tuberculosis or latent tuberculosis (as defined by a positive interferon gamma release assay)
  • active chronic hepatitis B or C or HIV
  • cancer or lymphoproliferative disorders within the 5 years before inclusion (with the exception of in situ cervical cancer and squamous or basal cell carcinoma with R0 resection)
  • past history of sigmoid diverticulitis
  • any active hepatic disease
  • hepatic failure; thrombocytopenia <50 G/L
  • neutropenia <0.5 G/L
  • history of moderate to severe congestive heart failure or demyelinating disease
  • recent stroke
  • current signs or symptoms of severe, progressive, or uncontrolled disease, not due to GCA, which contraindicates TCZ
  • severe and uncontrolled hypercholesterolemia
  • high cardiovascular risk (former cerebral or coronary vascular event, or vascular risk >20% at 10 years according to the Framingham risk score [24]); dementia; non-compliant patients
  • patients under ward of court, tutelage or legal guardianship.
  Contacts and Locations
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): NCT01910038


Locations
France
CHU de Caen - Hôpital Côte de Nacre
Caen, France, 14033
CHU de Dijon
Dijon, France, 21079
Chu Dupuytren
Limoges, France, 87042
Hôpital Edouard HERRIOT
Lyon, France, 69437
Hôpitaux privés de Metz - Site Sainte Blandine
Metz, France, 57045
Institut Mutualiste Montsouris
Paris, France, 75014
Hôpital La Pitié-Salpêtrière
Paris, France, 75651
Hôpital COCHIN
Paris, France, 75679
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
  More Information

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01910038     History of Changes
Other Study ID Numbers: Bonnotte PHRC N 2012
First Submitted: July 17, 2013
First Posted: July 29, 2013
Last Update Posted: November 30, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases