A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT03178487
Phase
PHASE2
Status
Completed

Conditions

  • Ankylosing Spondylitis (AS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Key Dates

Start date
Oct 24, 2017
Status verified
Feb 2023
Primary completion
Jan 21, 2019
Completion
Feb 17, 2022

Study Design

Enrollment
187 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib 15 mg
    Participants will receive 15 mg upadacitinib orally once a day for 14 weeks in Period 1 and continue to receive 15 mg upadacitinib orally once a day for an additional 90 weeks in Period 2.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo orally once a day for 14 weeks in Period 1. In Period 2 participants will receive 15 mg upadacitinib orally once a day for 90 weeks.

Primary Outcome Measure

Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14 [ Time Frame: Baseline and Week 14 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatolo /ID# 164446PhoenixArizona85032-9306-
AZ Arthritis and Rheumotology Research, PLLC /ID# 165705PhoenixArizona85032-9306-
David S. Hallegua MD /ID# 165090Beverly HillsCalifornia90211-
Covina Arthritis Clinic /ID# 165061CovinaCalifornia91722-
St. Joseph Health System /ID# 166166FullertonCalifornia92835-
Global Research Foundation /ID# 165130Los AngelesCalifornia90041-
Rheumatology Center of San Diego /ID# 166167San DiegoCalifornia92128-2549-
Colorado Arthritis Associates /ID# 164444LakewoodColorado80228-
Bay Area Arthritis and Osteo /ID# 165023BrandonFlorida33511-
LeJenue Research Associates /ID# 165202MiamiFlorida33126-
HMD Research LLC /ID# 205172OrlandoFlorida32819-
St. Lukes Clinic /ID# 165827MeridianIdaho83642-
Clinical Investigation Specialists - Skokie /ID# 164385SkokieIllinois60076-
Henry Ford Health System /ID# 165515DetroitMichigan48202-
Aa Mrc Llc /Id# 165100Grand BlancMichigan48439-
St. Lawrence Health System /ID# 165025PotsdamNew York13676-
DJL Clinical Research, PLLC /ID# 165044CharlotteNorth Carolina28210-8508-
Altoona Ctr Clinical Res /ID# 164470DuncansvillePennsylvania16635-
Clinical Research Ctr Reading /ID# 164876WyomissingPennsylvania19610-
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107HendersonvilleTennessee37075-6213-
Diagnostic Group Integrated He /ID# 165195BeaumontTexas77701-
Arth and Osteo Clin Brazo Valley /ID# 165194College StationTexas77845-

Find similar trials in Phoenix, AZ

By research site
Arizona Arthritis & Rheumatolo· Phoenix, AZAZ Arthritis and Rheumotology Research, PLLC· Phoenix, AZDavid S. Hallegua MD· Beverly Hills, CACovina Arthritis Clinic· Covina, CASt. Joseph Health System· Fullerton, CAGlobal Research Foundation· Los Angeles, CA

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