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NCT02794285 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 559
- Enrollment target
NCT02794285: Completed Phase 3 study, sponsored by AstraZeneca.
NCT02794285 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 559 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02794285, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 559 participants
- Enrollment target
Study Summary
The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
Primary Outcome
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years. The following AESIs were pre-defined: * Non-opp
Interventions
- DRUG Placebo
- BIOLOGICAL Anifrolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 559 participants |
| Start Date | 2016-06-30 |
| Est. Completion | 2021-12-21 |
| Phase | Phase 3 |
What the finished NCT02794285 record still lists
NCT02794285 is an interventional study that assigns participants to a tested intervention. The registered 559 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02794285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02794285 about?
NCT02794285 is a clinical study titled "Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus". The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.
What is the current status of trial NCT02794285?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 559 participants. The study started on 2016-06-30. Estimated completion is 2021-12-21.
What interventions are being tested in trial NCT02794285?
The interventions under investigation include: Placebo (DRUG), Anifrolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02794285?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02794285's enrollment target sits among peer trials
559 673rd of 2000 higher than 1,328 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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