bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Presence of sacroiliitis on MRI (according to ASAS/OMERACT criteria and based on central reading) (Rudwaleit et al. 2009d) and have at least 1 SpA feature OR Are positive for HLA-B27 and have at least 2 additional SpA features, according to the ASAS criteria (Sieper et al. 2009; Rudwaleit et al. 2009a) SpA features listed in Appendix 5 Patients have a history of back pain =3 months with age at onset 5.00 mg/L). 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. Examples of prior therapy may include but are not limited to physical therapy and NSAID treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Fulfillment of the modified New York (mNY) criteria (van der Linden et al. 1984) with sacroiliitis defined radiographically, based on central reading: sacroiliitis grade =2 bilaterally or grades 3 to 4 unilaterally Have a history of other systemic inflammatory diseases that might confound the evaluations of benefit from ixekizumab therapy (such as, but not limited to, lupus, vasculitis, or RA), or other chronic pain conditions (such as but not limited to fibromyalgia) Note: Patients with psoriasis who do not require systemic treatment, such as, but not limited to, oral agents or biologic therapies, can be included provided these patients fulfill the study entry criteria. Have active Crohn’s disease (CD) or active ulcerative colitis (UC) Note: Patients may be enrolled if they have had a history of inflammatory bowel disease (IBD), including CD and UC, but have had no exacerbation for =6 months prior to baseline, and, if currently on treatment, must be on stable treatment for =6 months prior to baseline. Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active nonradiographic axial spondyloarthritis (nonrad-axSpA) at Week 16;Secondary Objective: To compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W versus placebo in patients with active nonrad-axSpA at Week 16 and Week 52;Primary end point(s): Proportion of patients achieving an ASAS40 ; Timepoint(s) of evaluation of this end point: Week 16 (for regulatory agencies that require Week 16 as the primary endpoint) Week 52 (for regulatory agencies that require week 52 as the primary endpoint) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in (ASDAS) at Week 16 • Change from baseline in ASDAS at Week 52 • Change from baseline in (BASFI) at Week 16 • Change from baseline in BASFI at Week 52 • Proportion of patients achieving ASDAS inactive disease at Week 16 • Change from baseline in MRI of the (SIJ) [SPARCC] score) at Week 16 • Percent of patients without clinically meaningful changes in background therapy at Week 52 ;Timepoint(s) of evaluation of this end point: Weeks 16 and 52 depending on the end points. See above. | — |
Countries
Argentina, Austria, Brazil, Canada, Czech Republic, Finland, Germany, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed