Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01734382
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2012-11-22
Brief Title:
A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemraActemra Tocilizumab
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis SJIA Who Experience Laboratory Abnormalities During Treatment With Tocilizumab
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PART1 Participants in Part 1 Run-in-Phase of study will receive tocilizumab TCZ RoActemraActemra 12 milligrams per kilogram mgkg or 8 mgkg intravenously IV every 2 weeks Q2W for up to 24 weeks Participants who experience a laboratory abnormality during Part 1 may be eligible to move into Part 2 of the study
PART 2 This open-label Phase IV study will evaluate the efficacy safety pharmacokinetics pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly tocilizumab dosing that has since resolved Participants will receive tocilizumab 12 mgkg or 8 mgkg intravenously every 3 weeks After 5 consecutive infusions participants who experience an event of neutropenia thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab administration Anticipated time on study treatment is 52 weeks
PART 2 This open-label Phase IV study will evaluate the efficacy safety pharmacokinetics pharmacodynamics and immunogenicity of tocilizumab in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly tocilizumab dosing that has since resolved Participants will receive tocilizumab 12 mgkg or 8 mgkg intravenously every 3 weeks After 5 consecutive infusions participants who experience an event of neutropenia thrombocytopenia or liver enzyme abnormality will move to every 4 weeks tocilizumab administration Anticipated time on study treatment is 52 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-000444-10 | EUDRACT_NUMBER | None | None |