Rheumatoid Arthritis Clinical Trial
Official title:
A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients
Verified date | January 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigated the safety and tolerability of VAY736 administered as single ascending doses of intravenous infusion, subcutaneous injection and repeated subcutaneous injections in rheumatoid arthritis patients.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 22, 2018 |
Est. primary completion date | January 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Active disease despite methotrexate treatment 5 to 20 mg/week for Parts 1 and 2; methotrexate treatment 5 to 20 mg/week for Part 3 - Fulfilled 2010 American College of Rheumatolody (ACR)/European League Against Rheumatism (EULAR) classification criteria for rheumatoid arthritis for Part 1 and Part 2. For Part 3, fulfilled 2010 American College of Rheumatolody (ACR)/)/European League Against Rheumatism (EULAR) classification criteria or/and 1987 American College of Rheumatolody (ACR) classification criteria for rheumatoid arthritis; - Methotrexate = 16 weeks, stable dose = 8 weeks Exclusion Criteria: - Previous treatment with a B cell-depleting biologic agent. - Autoimmune disease other than RA except concurrent Sjogren's syndrome - Adult juvenile rheumatoid arthritis - ARA functional class IV disease of ACR Revised Steinbrocker Classification |
Country | Name | City | State |
---|---|---|---|
Germany | Novartis Investigative Site | Berlin |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability as measured by the number of patients wth adverse events | Part 1 The number of patients with adverse events after single intravenous (i.v.) dose of VAY736. Patients are assessed weekly up to 34 weeks post dose or until B cells reach the recovery criteria Part 2 The number of patients with adverse events after single subcutaneous (s.c.) dose of VAY736. Patients are assessed weekly, bi-weekly, then every 4, 8 and 12 weeks up to 188 weeks post dose or until B cells reach the recovery criteria. Part 3 The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of VAY736. Patients are assessed bi-weekly, then every 4 weeks and 8 weeks up to 27 weeks from the first dose. |
27-188 weeks | |
Primary | Absolute bioavailability of VAY736: The ratio of area under curve (AUC) for s.c dose and for intravenous dose | Part 2 The ratio of area under curve (AUC) for single s.c dose and intravenous dose is determined | 188 weeks | |
Primary | Plasma pharmacokinetics of VAY736: The area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCtau) | In Part 3: After the first and last s.c. doses, the area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCtau) will be determined |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | In Part 3: After the first and last s.c. doses, the Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) will be determined. |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: Observed maximum plasma concentration following drug administration (Cmax) | In Part 3: After the first and last s.c. doses, the Observed maximum plasma concentration following drug administration (Cmax) will be determined |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: Time to reach the maximum concentration after drug administration (Tmax) | In Part 3: After the first and last s.c. doses, the time to reach the maximum concentration after drug administration (Tmax) will be determined |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: The terminal elimination half-life (T1/2) | In Part 3: After the first and last s.c. doses, the terminal elimination half-life (T1/2) will be determined |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | In Part 3: After the first and last s.c. doses, Area under the plasma concentration-time curve from time zero to infinity (AUCinf) will be determined. |
27 weeks | |
Primary | Plasma pharmacokinetics of VAY736: concentration of VAY736 during the treatment period, before each dose (Ctrough) | In Part 3: After the first and last s.c. doses, the concentration of VAY736 during the treatment period, before each dose (Ctrough) will be determined |
27 weeks | |
Primary | Safety and tolerability as measured by the percentage of patients wth adverse events | Part 1 The percentage of patients with adverse events after single intravenous (i.v.) dose of VAY736. Patients are assessed weekly up to 34 weeks post dose or until B cells reach recovery criteria. Part 2 The percentage of patients with adverse events after single subcutaneous (s.c.) dose of VAY736. Patients are assessed weekly, bi-weekly, then every 4, 8 and 12 weeks up to 68 weeks post dose or until B cells reach recovery criteria.. Part 3 The percentage of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of VAY736. Patients are assessed bi-weekly, then every 4 weeks and 8 weeks up to 27 weeks from the first dose. |
27-188 weeks | |
Secondary | pharmacodynamics of VAY736 | B cell depletion/recovery after single i.v. dose of VAY736, single s.c. dose of VAY736 and multiple fixed s.c. doses of VAY736 administration in the 3 parts of the study | 27-188 weeks | |
Secondary | Immunogenicity of VAY736 | Immunogenicity after administration of single i.v. dose of VAY736, single s.c. dose of VAY736 and multiple fixed s.c. doses of VAY736 in 3 parts of the study. | 27-188 weeks | |
Secondary | Plasma bioavailability of VAY736: The ratio of area under curve (AUC) for repeated s.c doses and for intravenous dose | Part 3 The ratio of area under curve (AUC) for repeated s.c doses and for intravenous dose is determined | 27 weeks | |
Secondary | Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks | |
Secondary | Plasma pharmacokinetics of VAY736: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | The area under the plasma concentration-time curve from time zero to infinity (AUCinf) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively. | 34-188 weeks | |
Secondary | Plasma pharmacokinetics of VAY736: Observed maximum plasma concentration following drug Administration (Cmax) | The Observed maximum plasma concentration following drug administration (Cmax) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks | |
Secondary | Plasma pharmacokinetics of VAY736: Time to reach the maximum concentration after drug administration (Tmax) | The time to reach the maximum concentration after drug administration (Tmax) will be determined after single i.v. dose and s.c. dose of VAY736 in Part 1 and Part 2 respectively | 34-188 weeks |
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