This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting disease activity. A maximum of 11 participants from six centers in France that participated in the WA28119 study will be enrolled. The entire study duration is anticipated to be approximately 160 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
Hopital La Cavale Blanche; Rhumatologie
Brest, France
Hopital Claude Huriez; Internal Medicine
Lille, France
Hopital Emile Muller; Medecine Interne
Mulhouse, France
Percentage of subjects with Adverse Events
Time frame: Baseline up to 160 weeks
Baseline up to 160 weeks
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in Erythrocyte Sedimentation Rate Values
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Change from Baseline in C-Reactive Protein Values
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
Time frame: Baseline up to 156 weeks
Number of SC Tocilizumab Injections Administered
Time frame: Baseline up to 156 weeks
Total SC Tocilizumab Dose Administered
Time frame: Baseline up to 156 weeks
Duration of SC Tocilizumab Treatment
Time frame: Baseline up to 156 weeks
Duration of SC Tocilizumab Interruption
Time frame: Baseline up to 156 weeks
Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study
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Time frame: From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)