Tocilizumab for Patients With Giant Cell Arteritis

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT01450137
Phase
PHASE2
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Giant-cell arteritis (GCA) is an immune-mediated disease that mostly affects people older than 50 years of age. Glucocorticoid (GC) treatment dramatically alters the symptoms and course of GCA, reducing the likelihood of vascular complications that could lead e.g. to blindness. However, relapses usually occur when GC dosages are tapered, resulting in frequent re-treatment with high cumulative dosages of GC over time with substantial toxicity and morbidity (e.g. diabetes mellitus, infections, enhanced cardiovascular risk, osteoporotic fractures, cataracts). Therefore, novel therapies are needed that effectively reduce the dose and duration of GC treatment and provide more durable remissions of GCA. Tocilizumab (TCZ) is a humanized monoclonal antibody directed against the human interleukin-6 receptor (IL-6R). Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis. Inhibition of IL-6 and/or its receptor therefore represents a new and novel approach for the treatment of RA. The primary endpoint is the proportion of patients that have achieved complete remission of disease after treatment with TCZ compared to treatment with placebo at week 12. All patients will receive glucocorticoids in a standardized form.

Key Dates

Start date
Sep 30, 2011
Status verified
Sep 2018
Primary completion
Dec 31, 2014
Completion
Sep 30, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Tocilizumab 8mg/kg every 4 weeks until week 52.
  • Placebo Comparator: Placebo
    Placebo every 4 weeks until week 52.

Primary Outcome Measure

Number of Patients That Have Achieved Complete Remission of Disease [ Time Frame: 12 weeks ]

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