Active Radiographic Axial Spondylitis
Conditions
Interventions
Approximately 483 participants will be randomized in approximately 150 sites. Participants will be randomly assigned in a 1: 1: 1 to receive administrations of 45 mg or 90 mg of ustekinumab subcutaneo
Drug
Sponsors
LMK Serviços Médicos SS
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met; Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10; Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at screening - Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent; Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.; Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease - Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration; Participants who have ever received golimumab ; Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent; Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 - ASAS 40 is defined as a greater than or equal to (>=) 40 percent (%) improvement in 3 of 4 domains: Patient global; Total back pain; Function (Bath Ankylosing Spondylitis Functional Index [BASFI]); Inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness), with an absolute improvement of at least 2 on a 0 to 10 scale, and no deterioration at all in the remaining domain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an ASAS 20 Response at Week 24 - ASAS 20 is an improvement of >= 20% from baseline and absolute improvement from baseline of at least 1 on a 0 to 10 scale in at least 3 of the following 4 domains: Patient global; Total back pain;;Inflammation (average of the last 2 questions of the BASDAI concerning morning stiffness) and absence of deterioration from baseline (>=20% and worsening of at least 1 on a 0 to 10 scale) in the potential remaining domain;;Percentage of Participants who Achieve at Least 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 - BASDAI is defined as participant self-assessment using a visual analog scale (VAS; 0 to 10) on the following criteria: A. Fatigue; B. Spinal pain; C. Peripheral joint pain/swelling; D. Enthesitis; E. Intensity of morning stiffness; F. Duration of morning stiffness. The BASDAI = 0.2 (A + B + C + D + 0.5[E + F]);Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 - The BASFI is a participant’s self-assessment represented as a mean (VAS; 0 to 10) of 10 questions, 8 of which relate to the participant’s functional anatomy and 2 of which relate to a participant’s ability to cope with everyday life. An increase along the scale indicates a worsening condition; ;Percentage of Participants who Achieve Ankylosing Spondylitis Disease Activity Score (ASDAS) (CRP) Inactive Disease at Week 24 - The ASAS has developed a disease activity score (DAS) for use in AS, the Ankylosing Spondylitis Disease Activity Score (ASDAS). ASDAS (CRP) = 0.121 x Total back pain + 0.058 x Duration of morning stiffness + 0.110 x Patient global assessment + 0.073 x Peripheral joint pain/ swelling + 0.579 x Log (C-reactive protein [CRP]+1). Inactive disease is defined as an ASDAS (CRP) score less than (<) 1.3. | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Hungary, Mexico, Poland, Russian Federation, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed