Axial Spondyloarthritis Chronic Inflammatory disease affecting the spine and sacroiliac joint.
Conditions
Interventions
During the Lead-In Period (Period 1
24 weeks), patients will receive active
treatment in the form of ixekizumab 80 mg Q2W or ixekizumab 80 mg Q4W (open
label or blinded depending on the previous originating study).
During the Extensi
40 weeks):
(Group A): Patients who do not meet entry criteria for participation in the
randomized withdrawal-retreatment period will continue to receive uninterrupted
ixekizumab 80 mg Q2W or ixekizu
40 weeks),
o (Group A): Patients in Group A will continue their assigned treatment regimen
uninterrupted. Patients in Group A receiving ixekizumab 80 mg Q4W may have
their dose escalated to ixekizum
Axial spondyloarthritis
Inflammatory
Sponsors
Eli Lilly
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor). 2.Must agree to use a reliable method of birth control. 3.Have given written informed consent.
Exclusion criteria
Exclusion criteria: -Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered. -Have a known hypersensitivity to ixekizumab or any component of this investigational product. -Had investigational product permanently discontinued during a previous ixekizumab study. -Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the patient*s participation in the study. -Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol -Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score) -The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period | — |
Countries
The Netherlands
Outcome results
None listed