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NCT03675308 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
A Phase 3 study of Psoriatic Arthritis, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 964
- Enrollment target
- 20
- Study locations
NCT03675308: Active Phase 3 study of Psoriatic Arthritis, sponsored by AbbVie.
NCT03675308 is a Phase 3 study of Psoriatic Arthritis that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 964 participants, above the 833-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03675308, a Phase 3 study of Psoriatic Arthritis, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 964 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
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
- BIOLOGICAL Placebo
- BIOLOGICAL Risankizumab
Study Locations (20)
Florida
- Arthritis & Rheumatic Disease Specialties /ID# 210802 - Aventura
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099 - Boca Raton
- SIMED Health, LLC /ID# 207461 - Gainesville
- Sweet Hope Research Specialty Inc /ID# 209393 - Hialeah
- Jacksonville Center for Clinical Research /ID# 209876 - Jacksonville
- Rheum Assoc of Central FL /ID# 201622 - Orlando
- HMD Research LLC /ID# 208427 - Orlando
Arizona
- Sun Valley Arthritis Center Ltd. /ID# 200270 - Peoria
- AZ Arthritis and Rheumotology Research, PLLC /ID# 209873 - Phoenix
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875 - Tucson
- Southern Arizona VA Health Care System /ID# 209247 - Tucson
California
- Valerius Medical Group & Research Center /ID# 207428 - Los Alamitos
- Rheumatology Center of San Diego /ID# 201642 - San Diego
- Inland Rheum Clin Trials Inc. /ID# 201641 - Upland
- Medvin Clinical Research /ID# 211127 - Whittier
Connecticut
- New England Research Associates, LLC /ID# 207237 - Bridgeport
- Danbury Clinical Research, LLC /ID# 209517 - Danbury
- Arthritis & Osteoporosis Center /ID# 207236 - Hamden
Alabama
- Pinnacle Research Group /ID# 167955 - Anniston
Arkansas
- Arthritis and Rheumatism Associates /ID# 209882 - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 964 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2026-09-28 |
| Phase | Phase 3 |
What the registry record for NCT03675308 still lists
NCT03675308 is an interventional study that assigns participants to a tested intervention. The registered 964 participants enrollment target is mid-sized for trials with a published cap, above the 833-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (16% higher).
The record links to 1 condition, with Psoriatic Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03675308 names 20 study sites across 6 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT03675308 about?
NCT03675308 is a clinical study titled "A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy". The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
What is the current status of trial NCT03675308?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 964 participants. The study started on 2019-03-25. Estimated completion is 2026-09-28.
What conditions does trial NCT03675308 study?
This clinical trial studies the following conditions: Psoriatic Arthritis.
What interventions are being tested in trial NCT03675308?
The interventions under investigation include: Placebo (BIOLOGICAL), Risankizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03675308?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03675308 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03675308's enrollment target sits among peer trials
964 8th of 48 higher than 41 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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