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

Sponsor
Centre Hospitalier Universitaire Dijon
Study ID
NCT01910038
Phase
PHASE2
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

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

Interventions

Study Details

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%.

Key Dates

Start date
Nov 8, 2013
Status verified
Nov 2017
Primary completion
Dec 31, 2015
Completion
Jun 13, 2016

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

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

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