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NCT04115748 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT04115748: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT04115748 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115748, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 67 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 are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).
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 Adalimumab
- DRUG Filgotinib
- DRUG Placebo to match filgotinib
- DRUG Placebo to match adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2021-05-11 |
| Phase | Phase 3 |
Why NCT04115748 stopped before completion
NCT04115748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 4 interventions - of which Adalimumab is the first listed.
NCT04115748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115748 about?
NCT04115748 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive 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 are naive to biologic disease-modifying anti-rheumatic drug (DMARD)...
What is the current status of trial NCT04115748?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2019-12-03. Estimated completion is 2021-05-11.
What interventions are being tested in trial NCT04115748?
The interventions under investigation include: Adalimumab (DRUG), Filgotinib (DRUG), Placebo to match filgotinib (DRUG), Placebo to match adalimumab (DRUG).
Who is sponsoring clinical trial NCT04115748?
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 NCT04115748's enrollment target sits among peer trials
67 1796th of 2000 higher than 204 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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