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%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CHU de Caen - Hôpital Côte de Nacre
Caen, France
CHU de Dijon
Dijon, France
Chu Dupuytren
Limoges, France
Hôpital Edouard HERRIOT
Lyon, France
Percentage of patients in remission with a dose of prednisone ≤ 0.1 mg/kg/day
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.
Time frame: Week 26
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
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Hôpitaux privés de Metz - Site Sainte Blandine
Metz, France
Institut Mutualiste Montsouris
Paris, France
Hôpital La Pitié-Salpêtrière
Paris, France
Hôpital COCHIN
Paris, France