Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB BIOSCIENCES GmbH
With
Parexel
Age
18–45
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
* Spinal pain \> 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
* for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) \> upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
You may not be if
Presence of total Spinal Ankylosis ('bamboo spine')
Diagnosis of any other Inflammatory Arthritis
Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
History of or current chronic or recurrent infections
High risk of infection
Recent live vaccination
Concurrent malignancy or a history of malignancy
Class III or IV congestive heart failure - New York Heart Association (NYHA)
Demyelinating disease of the central nervous system
Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
