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NCT03104400 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
A Phase 3 study of Psoriatic Arthritis, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,705
- Enrollment target
- 20
- Study locations
NCT03104400 is a Phase 3 study of Psoriatic Arthritis that has completed, run by AbbVie. The registered enrollment target is 1,705 participants, above the 817-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT03104400, a Phase 3 study of Psoriatic Arthritis, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,705 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
Conditions Studied
Interventions
- DRUG Adalimumab
- DRUG Upadacitinib
- DRUG Placebo to Upadacitinib
- DRUG Placebo to Adalimumab
Study Locations (20)
California
- Covina Arthritis Clinic /ID# 159891 - Covina
- St. Joseph Heritage Healthcare /ID# 159980 - Fullerton
- C.V. Mehta MD, Med Corporation /ID# 161216 - Hemet
- Care Access Research, Huntingt /ID# 160038 - Huntington Beach
- Kotha and Kotha /ID# 159823 - La Mesa
- TriWest Research Associates- La Mesa /ID# 159887 - La Mesa
- Arthritis & Osteo Medical Ctr /ID# 166760 - La Palma
- University of California, Los Angeles /ID# 164542 - Los Angeles
- VA Sacramento Medical Center /ID# 164196 - Mather
- East Bay Rheumatology Medical /ID# 166382 - San Leandro
- Inland Rheum Clin Trials Inc. /ID# 159828 - Upland
- Medvin Clinical Research /ID# 160034 - Whittier
Arizona
- SunValley Arthritis Center, Lt /ID# 161221 - Peoria
- AZ Arthritis and Rheumotology Research, PLLC /ID# 159981 - Phoenix
- AZ Arthritis and Rheumotology Research, PLLC /ID# 160033 - Phoenix
- AZ Arthritis and Rheumotology Research, PLLC /ID# 160036 - Phoenix
- AZ Arthritis & Rheuma Research /ID# 160037 - Phoenix
- AZ Arth & Rheum Res /ID# 166381 - Tucson
Alabama
- Rheum Assoc of North Alabama /ID# 163231 - Huntsville
Arkansas
- Little Rock Diagnostics Clinic /ID# 165161 - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,705 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2024-09-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03104400
The ClinicalTrials.gov registry entry for NCT03104400 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,705 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 817-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (109% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Psoriatic Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Adalimumab is the first listed.
NCT03104400 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03104400 about?
NCT03104400 is a clinical study titled "A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)". This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate respons...
What is the current status of trial NCT03104400?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,705 participants. The study started on 2017-04-27. Estimated completion is 2024-09-09.
What conditions does trial NCT03104400 study?
This clinical trial studies the following conditions: Psoriatic Arthritis.
What interventions are being tested in trial NCT03104400?
The interventions under investigation include: Adalimumab (DRUG), Upadacitinib (DRUG), Placebo to Upadacitinib (DRUG), Placebo to Adalimumab (DRUG).
Who is sponsoring clinical trial NCT03104400?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03104400 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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