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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: Completed Phase 3 study of Psoriatic Arthritis, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI
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 |
What the finished NCT03104400 record still lists
NCT03104400 is an interventional study that assigns participants to a tested intervention. Its 1,705 participants enrollment target places it among the larger protocols in the corpus, above the 817-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (109% higher).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
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Where NCT03104400's enrollment target sits among peer trials
1,705 3rd of 48 higher than 46 of 48 other Psoriatic Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriatic Arthritis 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.
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