An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
- Conditions
- onradiographic Axial Spondylitis, AnkylosingMedDRA version: 18.0Level: LLTClassification code 10076297Term: Non-radiographic axial spondyloarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-000289-67-BE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
- Must have an age at nr-AxSpA onset of <= 45 years
- Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
- Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10
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 390
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
- Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
- Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
- Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
- Have received prior biologic therapy other than anti-TNFa
- Have received more than 1 prior anti-TNFa agent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA). ;Secondary Objective: Secondary Objectives:<br>-Efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes.<br>-Safety.<br>-Pharmacokinetics (PK) and immunogenicity.<br>-Time to flare after randomized withdrawal.;Primary end point(s): Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Score at Week 24.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Percentage of Participants Achieving ASAS 40 at Weeks 24.<br>-Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response.<br>-Percentage of Participant Who Achieve ASDAS (CRP) Inactive Disease (<1.3) at Week 24.;Timepoint(s) of evaluation of this end point: Week 24