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NCT01904292 · ClinicalTrials.gov registry record · Phase 1
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
A Phase 1 study of Juvenile Idiopathic Arthritis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 20
- Study locations
NCT01904292 is a Phase 1 study of Juvenile Idiopathic Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 52 participants, below the 296-participant average among 8 other Juvenile Idiopathic Arthritis trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT01904292, a Phase 1 study of Juvenile Idiopathic Arthritis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \<30 kg.
Conditions Studied
Interventions
- DRUG Tocilizumab
Study Locations (20)
São Paulo
- Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia - Ribeirão Preto
- Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia - São Paulo
- Universidade Federal de Sao Paulo - UNIFESP - São Paulo
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology - Chicago
- The University of Chicago;Department of Pediatrics - Chicago
North Carolina
- Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics - Charlotte
- Duke University - Durham
Ohio
- Cincinnati Children'S Hospital Medical Center; Division of Rheumatology - Cincinnati
- Cleveland Clinic Fndn - Cleveland
Other
- Hospital Gral de Niños Pedro Elizalde - Buenos Aires
- Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil - Córdoba
Arkansas
- Arkansas Children's Hospital Research Institute - Little Rock
Connecticut
- Connecticut Children's Medical Center; 5E Clinical Trials Unit - Hartford
New Jersey
- Hackensack University Medical Center; Pediatric Rheumatology - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-08-15 |
| Est. Completion | 2017-06-13 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904292
The ClinicalTrials.gov registry entry for NCT01904292 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 296-participant average among 8 other Juvenile Idiopathic Arthritis trials with a reported enrollment target (82% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Juvenile Idiopathic Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Tocilizumab is the first listed.
NCT01904292 reports 20 study locations spanning 14 distinct geographic areas - top geographies include São Paulo, Illinois, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01904292 about?
NCT01904292 is a clinical study titled "A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis". This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous ...
What is the current status of trial NCT01904292?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2013-08-15. Estimated completion is 2017-06-13.
What conditions does trial NCT01904292 study?
This clinical trial studies the following conditions: Juvenile Idiopathic Arthritis.
What interventions are being tested in trial NCT01904292?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT01904292?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904292 being conducted?
This trial has 20 study locations across Arkansas, Connecticut, Illinois, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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