Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
NCT01904292 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01904292 reports 20 study locations spanning 14 distinct geographic areas — top geographies include São Paulo, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01904292?
The interventions under investigation include: Tocilizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01904292?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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