Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Biopharma SRL
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients at least 18 years of age
Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
1. Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
2. Inflammatory back pain for at least 3 months
3. Age at symptom onset of less than 45 years
4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale
Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein
Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry
You may not be if
Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier
Active infection or history of recent serious infections
Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
Presence of active suicidal ideation, or moderately severe major depression or severe major depression
Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
