Study Condition(s): Axial Spondyloarthritis (Ankylosing Spondylitis)

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis (COAST-V)

Study Alias: RHBV

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02696785 {{ currentLocaleObject.registryAnchorText }}

Recruiting Recruiting

Study Purpose

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in participants with radiographic axial spondyloarthritis (rad-axSpA) who have never taken biological disease-modifying anti-rheumatic drugs (bDMARDs).

Key Participation Requirements Tool Tip Icon

All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria

Gender

Male Female

Age

18+ years

Time Commitment

Your participation could last up to 20 months and include 15 visits to the study center
  • Participant must be diagnosed with radiographic axial spondyloarthritis (rad-xSpA) with inflammation of the sacroiliac joint or region

  • Participant must be able to walk

  • Participants must not have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents

  • Participant must have a history of back pain greater than or equal to 3 months which began at age 45 or younger

  • Participant must not have received a live vaccine within 12 weeks or received a vaccine with Bacillus Calmette-Guerin (BCG) within the past year

  • Participant must not have had major surgery within 8 weeks of baseline and will not require surgery during the study

  • Female participant must not be pregnant or breastfeeding

Where to Participate

44 locations are currently available of 99 planned
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