A 52 Week Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients with Nonradiographic Axial Spondyloarthritis

Eli Lilly and Company0 个研究点目标入组 302 人开始时间: 2016年4月1日最近更新: 2024年9月9日

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•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
•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 <45 years.
•Have active nonrad-axSpA defined as BASDAI =4 and total back pain =4 on a NRS at screening and baseline (Sieper et al. 2009)
•Patients have objective signs of inflammation by presence of sacroiliitis on MRI (as defined by ASAS/OMERACT) or presence of elevated CRP (defined as CRP >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

•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

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