Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent must be obtained before any assessment is performed
Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period
You may not be if
History of exposure to other IL-17 or IL-23 inhibitor biologic drug
History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician