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NCT04115839 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT04115839: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT04115839 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115839, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.
Primary Outcome
ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: patient's global assessment of disease activity (PGADA) using a visual analogue scale (VAS) on a scale of 0 (very well) to 100 (very poor); physician's global assessment of disease activity (PHGADA) using a VAS on a scale of 0 (no disease activity) to 100 (maxim
Interventions
- DRUG Filgotinib
- DRUG Placebo to match filgotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 3 |
Why NCT04115839 stopped before completion
NCT04115839 is an interventional study that assigns participants to a tested intervention. The registered 106 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Filgotinib is the first listed.
NCT04115839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115839 about?
NCT04115839 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy". The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who have an inadequate response or are intolerant to biologic disease-m...
What is the current status of trial NCT04115839?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2019-11-13. Estimated completion is 2021-03-18.
What interventions are being tested in trial NCT04115839?
The interventions under investigation include: Filgotinib (DRUG), Placebo to match filgotinib (DRUG).
Who is sponsoring clinical trial NCT04115839?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04115839's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 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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