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NCT01455701 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT01455701 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 11 participants.
The verdict
NCT01455701, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.
Interventions
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-10-26 |
| Est. Completion | 2017-07-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01455701
The ClinicalTrials.gov registry entry for NCT01455701 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.
NCT01455701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01455701 about?
NCT01455701 is a clinical study titled "A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)". This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 w...
What is the current status of trial NCT01455701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2012-10-26. Estimated completion is 2017-07-13.
What interventions are being tested in trial NCT01455701?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT01455701?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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