A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 19

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria at screening or as specified:;Type of Patient and Disease Characteristics;Have an established diagnosis of rad-axSpA with sacroiliitis defined radiographically according to the mNY criteria Patients have a history of back pain *3 months with age at onset <45 years
Must have had an inadequate response, as determined by the investigator, to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
Patients must have a history of prior therapy for axSpA of at least 12 weeks prior to screening. If taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors, the dose must be stable for at least 2 weeks prior to baseline randomization.
Are ambulatory male or female patients *18 years of age at time of screening.
Have given written informed consent

Exclusion Criteria

Have total ankylosis of the spine
Have received any prior, or are currently receiving, treatment with biologic or other immunomodulatory agents
Had a live vaccination within 12 weeks or have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months
Have evidence or suspicion of active or latent TB
Have a known immunodeficiency or are immunocompromised.
Have active or history of malignant disease
Have had any major surgery within 8 weeks prior to baseline randomization, or will require major surgery during the study
Are women who are lactating or breastfeeding.
Women who are pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of patients achieving an Assessment of Spondyloarthritis<br /><br>International Society 40 (ASAS40) response </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Proportion of patients achieving an ASAS20 response<br /><br>* Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)<br /><br>* Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity<br /><br>Index 50 (BASDAI50) response<br /><br>* Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)<br /><br>* Proportion of patients achieving ASDAS inactive disease<br /><br>* Change from baseline in magnetic resonance imaging (MRI) of the spine<br /><br>(Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] Berlin<br /><br>score)<br /><br> Change from baseline in Short Form 36 (SF-36) physical component score (PCS)<br /><br>* Change from baseline in ASAS Health Index (ASAS-HI)</p><br>