Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-09 @ 4:10 AM
Study NCT ID:
NCT04042792
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)
Status:
COMPLETED
Status Verified Date:
2021-11
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:
ADA in PiRD
Brief Summary:
This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: