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NCT02165345 · ClinicalTrials.gov registry record · Phase 1
Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT02165345: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT02165345 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165345, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
This open-label extension of the JIGSAW studies (WA28117 \[NCT01904279\] and WA28118 \[NCT01904292\]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
Interventions
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2014-07-16 |
| Est. Completion | 2021-11-24 |
| Phase | Phase 1 |
What the finished NCT02165345 record still lists
NCT02165345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 1 intervention - of which Tocilizumab is the first listed.
NCT02165345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02165345 about?
NCT02165345 is a clinical study titled "Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis". This open-label extension of the JIGSAW studies (WA28117 \[NCT01904279\] and WA28118 \[NCT01904292\]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJ...
What is the current status of trial NCT02165345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2014-07-16. Estimated completion is 2021-11-24.
What interventions are being tested in trial NCT02165345?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT02165345?
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 NCT02165345's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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