A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Public ClinicalTrials.gov record NCT04169373. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04169373
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 734 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2019 (Actual)
- Primary completion
- Sep 2, 2021 (Actual)
- Completion
- Feb 28, 2025 (Actual)
- Last update posted
- Feb 24, 2026
2019 – 2025
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282 | Flagstaff | Arizona | 86001-6269 | — |
| AZ Arthritis and Rheumotology Research, PLLC /ID# 215113 | Phoenix | Arizona | 85032-9306 | — |
| Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731 | Tucson | Arizona | 85704 | — |
| Newport Huntington Medical Group /ID# 216281 | Huntington Beach | California | 92648-5994 | — |
| Inland Rheum & Osteo Med Grp /ID# 215807 | Upland | California | 91786 | — |
| Denver Arthritis Clinic /ID# 215346 | Denver | Colorado | 80230 | — |
| Tekton Research /ID# 215054 | Fort Collins | Colorado | 80528 | — |
| Arthritis & Rheumatic Disease Specialties /ID# 215306 | Aventura | Florida | 33180 | — |
| Sweet Hope Research Specialty Inc /ID# 215931 | Hialeah | Florida | 33016-1897 | — |
| Innovation Medical Research Center /ID# 216068 | Palmetto Bay | Florida | 33157-1737 | — |
| Conquest Research /ID# 215804 | Winter Park | Florida | 32789 | — |
| Great Lakes Clinical Trials /ID# 215790 | Chicago | Illinois | 60640 | — |
| Greater Chicago Specialty Physicians /ID# 216213 | Schaumburg | Illinois | 60195-3106 | — |
| Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055 | Skokie | Illinois | 60076 | — |
| Klein and Associates MD /ID# 214767 | Hagerstown | Maryland | 21740 | — |
| Tufts Medical Center /ID# 215925 | Boston | Massachusetts | 02111-1552 | — |
| Clinical Pharmacology Study Group /ID# 215293 | Worcester | Massachusetts | 01605 | — |
| Wayne State University Health Center /ID# 215930 | Detroit | Michigan | 48201-2153 | — |
| Advanced Rheumatology, PC /ID# 214973 | Lansing | Michigan | 48910 | — |
| St. Paul Rheumatology /ID# 215537 | Eagan | Minnesota | 55121 | — |
| Clinvest Research LLC /ID# 215785 | Springfield | Missouri | 65807 | — |
| CenterPointe Institute of Research /ID# 215793 | St Louis | Missouri | 63128-3841 | — |
| NYU Langone Orthopedic Center /ID# 215594 | New York | New York | 10016-2772 | — |
| St. Lawrence Health System /ID# 215844 | Potsdam | New York | 13676 | — |
| Cape Fear Arthritis Care /ID# 215927 | Leland | North Carolina | 28451 | — |
| Marietta Memorial Hospital /ID# 215929 | Marietta | Ohio | 45750-1635 | — |
| STAT Research, Inc. /ID# 215264 | Springboro | Ohio | 45066 | — |
| Health Research of Oklahoma /ID# 215117 | Oklahoma City | Oklahoma | 73103-2400 | — |
| Oregon Health and Science University /ID# 216446 | Portland | Oregon | 97239 | — |
| Altoona Ctr Clinical Res /ID# 214770 | Duncansville | Pennsylvania | 16635 | — |
| Tekton Research, Inc. /ID# 214923 | Austin | Texas | 78745 | — |
| Trinity Universal Research Associates - Carrollton /ID# 214948 | Carrollton | Texas | 75007 | — |
| Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805 | College Station | Texas | 77845 | — |
| JPS Rheumatology Clinic /ID# 215962 | Fort Worth | Texas | 76104-4917 | — |
| Memorial Rheumatology /ID# 216311 | Houston | Texas | 77024-2420 | — |
| Biopharma Informatic, LLC /ID# 215885 | Houston | Texas | 77043 | — |
| Biopharma Informatic - Park Row /ID# 215907 | Houston | Texas | 77084 | — |
| West Texas Clinical Research /ID# 215928 | Lubbock | Texas | 79410-1198 | — |
| Trinity Universal Research Associates, Inc /ID# 215189 | Plano | Texas | 75024-5283 | — |
| Rheumatology and Pulmonary Clinic /ID# 214946 | Beckley | West Virginia | 25801 | — |
| West Virginia Research Inst /ID# 214921 | South Charleston | West Virginia | 25309 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04169373, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04169373 live on ClinicalTrials.gov.