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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 January 2021 |
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Main ID: |
NCT03923738 |
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Date of registration:
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19/04/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
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Scientific title:
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A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis |
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Date of first enrolment:
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August 5, 2019 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03923738 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of GCA as classified according to protocol-specified criteria;
- Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.
Exclusion Criteria:
- Treatment with any other investigational agent besides TCZ within 12 weeks (or 5
half-lives of the investigational drug, whichever is longer) prior to screening;
- Evidence of serious uncontrolled disease;
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
or other infections;
- Active TB requiring treatment within the previous 3 years.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Giant Cell Arteritis
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Intervention(s)
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Drug: Tocilizumab
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Primary Outcome(s)
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Maximum Serum Concentration (Cmax) of TCZ
[Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281]
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Area Under the Concentration-Time Curve over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ
[Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281]
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Percentage of Participants with Adverse Events
[Time Frame: From Baseline through Day 281]
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Trough Serum Concentration (Ctrough) of TCZ
[Time Frame: Days 1, 57, 85, 113, 120, 127, 134, 141, 197, 225, 253, 260, 267, 274 and 281]
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Secondary Outcome(s)
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Serum Concentration of Interleukin-6 (IL-6)
[Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281]
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Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
[Time Frame: On Days 1, 85, 113, 141, 225, 253 and 281]
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Erythrocyte Sedimentation Rate (ESR)
[Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281]
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Serum Concentration of C-Reactive Protein (CRP)
[Time Frame: At screening, Days 1, 29, 57, 85, 113, 120, 127, 134, 141, 169, 197, 225, 253, 260, 267, 274 and 281]
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Secondary ID(s)
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WP41152
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2018-004718-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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