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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01910038
• Date of registration: 17/07/2013
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire Dijon
• Public title: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. HORTOCI
• Scientific title: Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
• Date of first enrolment: November 8, 2013
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01910038
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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-a, 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 de?ned 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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks

Primary Outcome(s)

Percentage of patients in remission with a dose of prednisone = 0.1 mg/kg/day [Time Frame: Week 26]

Secondary Outcome(s)

Factors associated with the occurrence of relapse [Time Frame: Until Week 52]

Frequency and type of adverse effects encountered [Time Frame: Until Week 52]

Percentage of relapses [Time Frame: Week 26 and Week 52]

The cumulative dose of prednisone. [Time Frame: Weeks 26 and 52]

Time to the first relapse [Time Frame: Until Week 52]

Secondary ID(s)

Bonnotte PHRC N 2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors