Tocilizumab
Drug162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
Other names: RO4877533
NCT Number: NCT03202368
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 3
Hopital La Cavale Blanche; Rhumatologie, Brest, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
Other names: RO4877533
Time frame: Baseline up to 160 weeks
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Time frame: Baseline (Week 0), Weeks 48, 96, 156
Time frame: Baseline up to 156 weeks
Time frame: Baseline up to 156 weeks
Time frame: Baseline up to 156 weeks
Time frame: Baseline up to 156 weeks
Time frame: Baseline up to 156 weeks
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)
Hoffmann-La Roche
Industry
An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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