A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT03129100
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ixekizumab — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Key Dates

Start date
May 9, 2017
Status verified
May 2022
Primary completion
May 26, 2020
Completion
May 27, 2021

Study Design

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

Arms

  • Experimental: Ixekizumab (IXE) 80Q4W
    Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).
  • Experimental: Ixekizumab (IXE) 80Q2W
    Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).
  • Placebo Comparator: Placebo
    Participants received subcutaneous dose of placebo.

Primary Outcome Measure

Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) [ Time Frame: Week 64 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology ResearchPhoenixArizona85032-
Care Access Research - Huntington BeachHuntington BeachCalifornia92648-
Desert Medical AdvancesPalm DesertCalifornia92260-
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLCColorado SpringsColorado80920-
Clinical Research Center of CT/NYDanburyConnecticut06810-
Arthritis Rheumatic Disease SpecialtiesAventuraFlorida33180-
Sarasota Arthritis CenterSarasotaFlorida34239-
Marietta RheumatologyMariettaGeorgia30060-
Institute of Arthritis ResearchIdaho FallsIdaho83404-
Center for Arthritis & OsteoporosisElizabethtownKentucky42701-
Klein and Associates MD, PACumberlandMaryland21502-
Klein and Associates MD, PAHagerstownMaryland21740-
Arthritis Consultants Inc.St LouisMissouri63141-
Glacier View Research InstituteKalispellMontana59901-
Physician Research Collaboration, LLCLincolnNebraska68516-
Shanahan Rheumatology & Immunotherapy, PLLCRaleighNorth Carolina27617-
Carolina Arthritis AssociatesWilmingtonNorth Carolina28401-
Oregon Health and Science UniversityPortlandOregon97239-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Articularis Healthcare Group, INC dba Columbia Arthritis CtrColumbiaSouth Carolina29204-
Articularis Healthcare d/b/a/ Low Country Rheumatology, PASummervilleSouth Carolina29486-
Univ of Texas Health Science Center - HoustonHoustonTexas77030-
Arthritis Northwest PLLCSpokaneWashington99204-

Find similar trials in Phoenix, AZ

By research site
Arizona Arthritis & Rheumatology Research· Phoenix, AZCare Access Research - Huntington Beach· Huntington Beach, CADesert Medical Advances· Palm Desert, CAArthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC· Colorado Springs, COClinical Research Center of CT/NY· Danbury, CTArthritis Rheumatic Disease Specialties· Aventura, FL

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