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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001173-24 | EudraCT Number |
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This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference VAY736 Drug Product | Active Comparator | Powder for solution for injection / infusion |
|
| Test VAY736 Drug Product | Experimental | Solution for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ianalumab | Biological | Human monoclonal antibody (mAb) of type IgG1/κ binding to B-cell activating-receptor (BAFF-R) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by the number of patients with adverse events | The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab | Week 0 - 112 |
| Pharmacokinetic comparability at steady state - AUCtau | The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau) | Week 8 - 12 |
| Pharmacokinetic comparability at steady state - Cmax | Observed maximum serum concentration of ianalumab following drug administration (Cmax) | Week 8 - 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic comparability after the first dose - AUCtau | The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau) | Week 0 - 4 |
| Pharmacokinetic comparability after the first dose - Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 10117 | Germany | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to results from the Novartis Clinical Trial Results Website | View source |
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000656267 | ianalumab |
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|
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
| Week 0 - 4 |
| Pharmacokinetic comparability after the first dose - Tmax | Time to reach the maximum concentration after drug administration (Tmax) | Week 0 - 4 |
| Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf | The area under the serum ianalumab concentration-time curve from time zero to infinity (AUCinf) | Week 8 - 12 |
| Pharmacokinetic comparability after the last dose - Tmax | Time to reach the maximum concentration after drug administration (Tmax) | Week 8 - 12 |
| Pharmacokinetic comparability after the last dose - T1/2 | The terminal elimination half-life (T1/2) | Week 8 - 12 |
| Pharmacokinetic comparability at the end of each dosing interval - Ctrough | Observed minimum serum ianalumab concentration following drug administration (Ctrough) | Week 0 - 12 |
| Pharmacodynamic effect as measured by B-cell level | Circulating B cells (CD19+) | Week 0 - 112 |
| Immunogenicity as measured by Anti-Drug Antibodies | Anti-ianalumab antibodies (ADA); incidence of ADA positive patients and correlation with AEs, PK and clinical outcomes | Week 0 - 112 |
| Amman |
| 11941 |
| Jordan |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |