A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluatingthe Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFa RefractorySubjects With Active Radiographic Axial Spondyloarthritis
- Conditions
- Axial SpondyloarthritisMedDRA version: 18.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-000288-16-HU
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 315
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 greaterthan 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 483
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Percentage of Participants Achieving an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24;Secondary Objective: -Percentage of Participants Achieving an ASAS 20 Response at Week 24<br>-Percentage of Participants who Achieve at Least 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24<br>-Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at<br>Week 24<br>-Percentage of Participants who Achieve Ankylosing Spondylitis Disease Activity Score (ASDAS) (CRP) Inactive Disease at Week 24;Primary end point(s): The primary endpoint is the proportion of subjects who achieve an ASAS 40 response at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To control for multiplicity for the primary endpoint analysis and the major secondary endpoint analyses, the 4 major secondary analyses listed below will be performed sequentially contingent upon the success of the primary statistical analysis in that treatment group comparison. Otherwise, the p-values for the<br>subsequent endpoints will be considered as supportive analyses. The following prespecified order will be used to analyze the major secondary endpoints.<br>-The proportion of subjects who achieve an ASAS 20 at Week 24.<br>-The proportion of subjects who achieve at least a 50% improvement from baseline in BASDAI at Week 24.<br>-The change from baseline in BASFI at Week 24.<br>-The proportion of subjects who achieve ASDAS (CRP) inactive disease (<1.3) at Week 24.;Timepoint(s) of evaluation of this end point: Week 24