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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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20 August 2018 |
Main ID: |
EUCTR2015-000289-67-CZ |
Date of registration:
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10/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
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Scientific title:
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis |
Date of first enrolment:
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13/10/2015 |
Target sample size:
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390 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000289-67 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Czech Republic
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France
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Germany
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Hungary
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Korea, Republic of
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Mexico
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Poland
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Russian Federation
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Taiwan
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Ukraine
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United Kingdom
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Contacts
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Name:
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Clinical Registry group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International N.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: - 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Nonradiographic Axial Spondylitis, Ankylosing MedDRA version: 18.0
Level: LLT
Classification code 10076297
Term: Non-radiographic axial spondyloarthritis
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO1275 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Primary end point(s): Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Score at Week 24.
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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).
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Objective: Secondary Objectives: -Efficacy related to improving physical function, range of motion, health-related quality of life, and other health outcomes. -Safety. -Pharmacokinetics (PK) and immunogenicity. -Time to flare after randomized withdrawal.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary end point(s): -Percentage of Participants Achieving ASAS 40 at Weeks 24.
-Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) 50 Response.
-Percentage of Participant Who Achieve ASDAS (CRP) Inactive Disease (<1.3) at Week 24.
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Secondary ID(s)
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2015-000289-67-BE
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CNTO1275AKS3003
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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