Ankylosing Spondylitis Bechterew's disease
Conditions
Interventions
Period 1: subjects will take one tablet of upadacitinib (Dose A) or placebo
once daily for 14 weeks.
Period 2: subjects will take one tablet of upadacitinib (Dose A) once daily for
194 weeks.
Sponsors
Site Management & Monitoring
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female >= 18 years of age., 2. Subject with a clinical diagnosis of AS and meeting the modified New York Criteria for AS., 3. Subject must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits., 4. Subject has had an inadequate response to at least two NSAIDs over an at least 4-week period in total at maximum recommended or tolerated doses, or subject has an intolerance to or contraindication for NSAIDs as defined by the Investigator., 5. If entering the study on concomitant MTX, leflunomide, SSZ and/or hydroxychloroquine, subject must be on a stable dose of MTX (
Exclusion criteria
Exclusion criteria: 1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib)., 2. Prior exposure to any biologic therapy with a potential therapeutic impact on spondyloarthritis (SpA)., 3. Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline Visit. Inhaled or topical corticosteroids are allowed., 4. Subject on any other DMARDs (other than those allowed), thalidomide, or apremilast within 28 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit., 5. Subject on opioid analgesics (except for combination acetaminophen/codeine or acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14 days prior to the Baseline Visit., 6. Subject has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age., 7. Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase (AST) > 2 × ULN; serum alanine transaminase (ALT) > 2 × ULN; estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with Assessment of SpondyloArthritis international Society (ASAS) 40 response (It is defined as a >= 40% improvement and an absolute improvement of >= 2 units (on a scale of 0 to 10) from Baseline in at least three of the following four domains, with no worsening at all in the remaining domain: a. Patient's Global Assessment b. Pain c. Function d. Inflammation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS); 2. Change from Baseline in MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score (Spine); 3. Proportion of subjects with BASDAI 50 response; 4. Change from Baseline in Ankylosing Spondylitis Quality of Life (AS QoL); 5. Proportion of subjects with ASAS partial remission (PR); 6. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI); 7. Change from Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin); 8. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES); 9. Change from Baseline in Work Productivity and Activity Impairment (WPAI); 10. Change from Baseline in ASAS Health Index (HI); 11. ASAS 20; 12. Change from Baseline in MRI Spondyloarthritis Research Consortium of Canada (SPARCC) score Sacroiliac (SI) joints. | — |
Countries
Netherlands
Outcome results
None listed