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Anti-TNFα Refractory Subjects With Active Radiographic Axial Spondyloarthritis Treatment Study

Clinical Trial Title: 
A phase 3 study of a monoclonal antibody therapy for the treatment of anti-TNFα refractory subjects with active radiographic axial spondyloarthritis.
Clinical Trial Protocol ID: 
15040603
Clinical Trial Investigator Name: 
Joel Block, MD
Clinical Trial Protocol Description: 

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 received no more than one anti-TNFα drug. About 327 subjects are expected to participate in this study worldwide. At Rush University Medical Center we expect to recruit approximately 4 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.

Clinical Trial Eligibility Criteria: 

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 only used one anti-TNFα drug 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:  golimumab, tofacitinib, ustekinumab, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, brodalumab, 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.

Clinical Trial Area: 
Arthritis and Other Rheumatic Diseases
Contact Phone: 
(312) 563-2955
Contact Name: 
Joshlean Fair, MS