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NCT04169373 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 734
- Enrollment target
NCT04169373: Completed Phase 3 study, sponsored by AbbVie.
NCT04169373 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 734 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169373, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 734 participants
- Enrollment target
Study Summary
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). * To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). * To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib.
Primary Outcome
ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * F
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 734 participants |
| Start Date | 2019-11-26 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 3 |
What the finished NCT04169373 record still lists
NCT04169373 is an interventional study that assigns participants to a tested intervention. The registered 734 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04169373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04169373 about?
NCT04169373 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis". This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial...
What is the current status of trial NCT04169373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 734 participants. The study started on 2019-11-26. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT04169373?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT04169373?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04169373's enrollment target sits among peer trials
734 482nd of 2000 higher than 1,517 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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