Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 88 of 357 for:    dupuytren

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

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: NCT01910038
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date  ICMJE July 17, 2013
First Posted Date  ICMJE July 29, 2013
Last Update Posted Date November 30, 2017
Actual Study Start Date  ICMJE November 8, 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Percentage of Treg [ Time Frame: baseline ]
Change History Complete list of historical versions of study NCT01910038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
Official Title  ICMJE Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
Brief Summary 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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Giant Cell Arteritis
Intervention  ICMJE Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks
Study Arms  ICMJE 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).
Intervention: Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks
Publications * Samson M, Devilliers H, Ly KH, Maurier F, Bienvenu B, Terrier B, Charles P, Guillevin L, Besancenot JF, Liozon E, Fauchais AL, Loffroy R, Binquet C, Audia S, Seror R, Mariette X, Bonnotte B. Tocilizumab as an add-on therapy to glucocorticoids during the first 3 months of treatment of Giant cell arteritis: A prospective study. Eur J Intern Med. 2018 Nov;57:96-104. doi: 10.1016/j.ejim.2018.06.008. Epub 2018 Jul 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 13, 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01910038
Other Study ID Numbers  ICMJE Bonnotte PHRC N 2012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date November 2017

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