Anti-TNFα Naïve Subjects With Active Radiographic Axial Spondyloarthritis Treatment Study
The purpose of this study is to determine the effective dose and safety of a monoclonal antibody therapy in the treatment of axial spondyloarthritis symptoms in individuals who have never received an anti-TNFα drug. About 327 subjects are expected to participate in this study worldwide. At Rush University Medical Center we expect to recruit approximately 5 subjects in total. This study drug is delivered by subcutaneous injection (injected below the skin) every 4 weeks, and subjects are randomly assigned to one of three treatment arms.
In order to participate you must meet the following criteria:
- Have a diagnosis of definite axial spondyloarthritis with clinical symptoms of lower back pain and stiffness, limitation of motion of the lower back, and limited chest expansion.
- Have never used anti-TNFα drugs for your axial spondyloarthritis (anti-TNFα drugs: Remicade, Enbrel, Humira, etc.).
- Have used at least 2 NSAID pain relievers to treat symptoms of axial spondyloarthritis (NSAID: naproxen, acetaminophen, ibuprofen, etc.).
You will be excluded from the study if any of the following criteria apply to you:
- Have other inflammatory diseases such as rheumatoid arthritis, lupus, or Lyme disease.
- Have ever received any of the following drugs: tofacitinib, ustekinumab, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, brodalumab, tidrakizumab, secukinumab, ixekizumab, chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
- Have a history of multiple sclerosis or optic neuritis.
This is a partial list of inclusion and exclusion criteria.