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NCT02682823 · ClinicalTrials.gov registry record · Phase 4
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT02682823: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT02682823 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 91 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02682823, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study Summary
This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.
Primary Outcome
Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks inclu
Interventions
- DRUG Tocilizumab
- DEVICE AI-1000 G2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2016-03-21 |
| Est. Completion | 2016-07-29 |
| Phase | Phase 4 |
What the finished NCT02682823 record still lists
NCT02682823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Tocilizumab is the first listed.
NCT02682823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02682823 about?
NCT02682823 is a clinical study titled "Tocilizumab Real-Life Human Factors (RLHFs) Validation Study". This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The stud...
What is the current status of trial NCT02682823?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2016-03-21. Estimated completion is 2016-07-29.
What interventions are being tested in trial NCT02682823?
The interventions under investigation include: Tocilizumab (DRUG), AI-1000 G2 (DEVICE).
Who is sponsoring clinical trial NCT02682823?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02682823's enrollment target sits among peer trials
91 884th of 2000 higher than 1,115 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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