Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT02721966
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Other protocol-defined inclusion and exclusion criteria may have applied.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02721966
Study Brief:
Protocol Section:
NCT02721966