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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002716-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab: GCA Flare or Persistent Disease Activity | Experimental | Participants who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119, will receive SC tocilizumab in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | 162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with Adverse Events | Baseline up to 160 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline up to 160 weeks | Baseline (Week 0), Weeks 48, 96, 156 | |
| Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score | Baseline (Week 0), Weeks 48, 96, 156 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital La Cavale Blanche; Rhumatologie | Brest | 29609 | France | |||
| Hopital Claude Huriez; Internal Medicine |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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|
| Change from Baseline in Erythrocyte Sedimentation Rate Values | Baseline (Week 0), Weeks 48, 96, 156 |
| Change from Baseline in C-Reactive Protein Values | Baseline (Week 0), Weeks 48, 96, 156 |
| Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab | Baseline up to 156 weeks |
| Number of SC Tocilizumab Injections Administered | Baseline up to 156 weeks |
| Total SC Tocilizumab Dose Administered | Baseline up to 156 weeks |
| Duration of SC Tocilizumab Treatment | Baseline up to 156 weeks |
| Duration of SC Tocilizumab Interruption | Baseline up to 156 weeks |
| Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study | From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline) |
| Lille |
| 59037 |
| France |
| Hopital Emile Muller; Medecine Interne | Mulhouse | 68070 | France |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |