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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04929210
Registration number
NCT04929210
Ethics application status
Date submitted
11/06/2021
Date registered
18/06/2021
Date last updated
22/05/2024
Titles & IDs
Public title
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
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Scientific title
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
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Secondary ID [1]
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2021-000465-32
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Secondary ID [2]
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CR109043
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Universal Trial Number (UTN)
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Trial acronym
STAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo
Experimental: Group 1: Guselkumab and Placebo - Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Experimental: Group 2: Guselkumab - Participants will receive guselkumab SC.
Experimental: Group 3: Placebo followed by Guselkumab - Participants will receive matching placebo and will cross over to receive guselkumab SC.
Treatment: Drugs: Guselkumab
Guselkumab will be administered as subcutaneous injection.
Treatment: Drugs: Placebo
Matching placebo will be administered as subcutaneous injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
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Assessment method [1]
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BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
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Assessment method [1]
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The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
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Assessment method [2]
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DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
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Assessment method [3]
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HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
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Assessment method [4]
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Percentage of participants with IGA 0/1 response at week 24 among the participants with >= 3 percent (%) BSA psoriatic involvement and an IGA score of >= 2 (mild) at baseline will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given timepoint. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
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Assessment method [5]
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Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
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Assessment method [6]
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Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
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Assessment method [7]
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Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
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Assessment method [8]
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Percentage of participants who achieve ASAS 40 response at Week 24 will be reported. ASAS 40 defined as improvement from baseline of >= 40% and with an absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Participant's global assessment (0 to 10 cm; 0=very well, 10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); no worsening at all from baseline in remaining domain.
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Timepoint [8]
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Week 24
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Secondary outcome [9]
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Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
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Assessment method [9]
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Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.
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Timepoint [9]
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Week 24
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Secondary outcome [10]
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Change from Baseline in SPARCC Score for MRI Spine at Week 24
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Assessment method [10]
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Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.
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Timepoint [10]
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Baseline and Week 24
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Secondary outcome [11]
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Number of Participants with Adverse Events (AEs)
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Assessment method [11]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [11]
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Up to 60 weeks
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Secondary outcome [12]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [12]
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Timepoint [12]
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Up to 60 weeks
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Secondary outcome [13]
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Number of Participants with Reasonably Related AEs
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Assessment method [13]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [13]
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Up to 60 weeks
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Secondary outcome [14]
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Number of Participants with AEs Leading to Discontinuation of Study Intervention
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Assessment method [14]
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Number of participants with AEs leading to discontinuation of study intervention will be reported.
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Timepoint [14]
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Up to 60 weeks
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Secondary outcome [15]
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Number of Participants with Infections
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Assessment method [15]
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Number of participants with infections will be reported.
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Timepoint [15]
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Up to 60 weeks
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Secondary outcome [16]
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Number of participants with Injection-Site Reactions
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Assessment method [16]
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Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.
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Timepoint [16]
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Up to 60 weeks
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Secondary outcome [17]
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Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
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Assessment method [17]
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Number of participants with laboratory abnormalities (chemistry, hematology) by maximum toxicity (CTCAE 5.0) grades will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
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Timepoint [17]
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Up to 60 weeks
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Secondary outcome [18]
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Serum Guselkumab Concentration Over Time
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Assessment method [18]
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Serum guselkumab concentration over time will be reported.
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Timepoint [18]
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Up to 60 weeks
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Secondary outcome [19]
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Number of Participants with Antibodies to Guselkumab
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Assessment method [19]
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Number of participants with antibodies to guselkumab will be reported.
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Timepoint [19]
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Up to 60 weeks
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Eligibility
Key inclusion criteria
- Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first
administration of study intervention and meet classification criteria for psoriatic
arthritis (CASPAR) criteria at screening
- Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender
joints at screening and at baseline and b) C-reactive protein (CRP) greater than or
equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central
laboratory, and despite previous non-biologic disease modifying antirheumatic drug
(DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine
and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of
Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
- Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least
4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
- Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm)
diameter and/or nail changes consistent with psoriasis, or documented history of
plaque psoriasis
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- Has other inflammatory diseases that might confound the evaluations of benefit of
guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing
spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a
primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme
disease
- Has previously received any biologic treatment
- Has ever received a Janus kinase (JAK) inhibitor including but not limited to
tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any
other investigational JAK inhibitor
- Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6
thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4
weeks of the first administration of study intervention
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/02/2026
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Actual
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Sample size
Target
405
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Emeritus Research - Camberwell
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Recruitment hospital [2]
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Southern Clinical Research - Hobart
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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Rheumatology Research Unit - Maroochydore
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Recruitment hospital [5]
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Skin Health Institute Inc. - Melbourne
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Recruitment hospital [6]
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Eastern Health - Box Hill Hospital - Melbourne
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Recruitment postcode(s) [1]
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3124 - Camberwell
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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4558 - Maroochydore
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Recruitment postcode(s) [5]
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3053 - Melbourne
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Recruitment postcode(s) [6]
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3128 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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La Plata
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sfia
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Bulgaria
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Sofia
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Bulgaria
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Targovishte
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno Zidenice
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Czechia
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Brno
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Czechia
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Hlucin
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Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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Praha
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Czechia
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Uherske Hradiste
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Denmark
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Frederiksberg
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Denmark
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Glostrup
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Denmark
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Køge
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Denmark
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Vejle
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Georgia
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Kutaisi
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Georgia
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T'bilisi
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Georgia
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Tbilisi
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Georgia
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Tnilisi
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Ratingen
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Gyula
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Hungary
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Kistarcsa
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Hungary
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Székesfehérvár
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Hungary
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Veszprem
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Israel
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Haifa
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Israel
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Hifa
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Israel
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Kfar-Sava
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Israel
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Ramat Gan
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Italy
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Ancona
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0
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Italy
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Monserrato
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Italy
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Reggio Emilia
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Italy
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Roma
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0
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Italy
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Rozzano (MI)
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0
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Italy
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Verona
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0
0
Malaysia
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State/province [61]
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0
Batu Caves
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Malaysia
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George Town
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0
0
Malaysia
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State/province [63]
0
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Johor Bahru
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Country [64]
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0
Malaysia
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State/province [64]
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0
Kuala Lumpur
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Country [65]
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Malaysia
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State/province [65]
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Seremban
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Country [66]
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Philippines
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State/province [66]
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Cebu City
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Country [67]
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Philippines
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State/province [67]
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Davao City
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Country [68]
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Philippines
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State/province [68]
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Lipa
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Country [69]
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Philippines
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Manila
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Country [70]
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Philippines
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San Fernando
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Country [71]
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Poland
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Bialystok
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Country [72]
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Poland
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Bydgoszcz
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Country [73]
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Poland
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Bytom
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Poland
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Elblag
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Poland
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Krakow
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Country [76]
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Poland
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Lodz
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Poland
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Lublin
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Country [78]
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Poland
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Nadarzyn
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Country [79]
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Poland
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State/province [79]
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Nowa Sol
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Country [80]
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Poland
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State/province [80]
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Poznan
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Country [81]
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Poland
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State/province [81]
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Swidnik
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Country [82]
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Poland
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Torun
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Country [83]
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Poland
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Warsaw
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Country [84]
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Poland
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State/province [84]
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Warszawa
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Country [85]
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Poland
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Wroclaw
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Country [86]
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Portugal
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State/province [86]
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Braga
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Country [87]
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Portugal
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State/province [87]
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Guarda
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Country [88]
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Portugal
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State/province [88]
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Lisboa
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Country [89]
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Portugal
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State/province [89]
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Ponte de Lima
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Country [90]
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Portugal
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Porto
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Country [91]
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Russian Federation
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State/province [91]
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Barnaul
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Country [92]
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Russian Federation
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State/province [92]
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Chelyabinsk
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Country [93]
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Russian Federation
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State/province [93]
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Ekaterinbourg
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Country [94]
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Russian Federation
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State/province [94]
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Izhevsk
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Country [95]
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Russian Federation
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State/province [95]
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Kemerovo
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Country [96]
0
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Russian Federation
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State/province [96]
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Korolev
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Country [97]
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Russian Federation
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State/province [97]
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Krasnoyarsk
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Russian Federation
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Moscow
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Country [99]
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Russian Federation
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Omsk
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Russian Federation
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Orenburg
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Russian Federation
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Perm
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Russian Federation
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Petrozavodsk
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Country [103]
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Russian Federation
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Rostov
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Russian Federation
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State/province [104]
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St. Petersburg
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Country [105]
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Russian Federation
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State/province [105]
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Tolyatti
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Country [106]
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Russian Federation
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State/province [106]
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Ufa
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Country [107]
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Russian Federation
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State/province [107]
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Yaroslavl
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Country [108]
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Slovakia
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State/province [108]
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Martin
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Country [109]
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Slovakia
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State/province [109]
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Nove Mesto nad Vahom
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Country [110]
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Slovakia
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State/province [110]
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Piestany
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Country [111]
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Slovakia
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State/province [111]
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Poprad
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Country [112]
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Slovakia
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State/province [112]
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Rimavska Sobota
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Country [113]
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Spain
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State/province [113]
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A Coruna
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Country [114]
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Spain
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State/province [114]
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Barakaldo
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Country [115]
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Spain
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State/province [115]
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Barcelona
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Country [116]
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Spain
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State/province [116]
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Bilbao
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Country [117]
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Spain
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State/province [117]
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Cordoba
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Country [118]
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0
Spain
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State/province [118]
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Madrid
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Country [119]
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0
Spain
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State/province [119]
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Málaga
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Country [120]
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0
Spain
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State/province [120]
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Sabadell
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Country [121]
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Spain
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State/province [121]
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Santiago de Compostela
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Country [122]
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Spain
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State/province [122]
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Sevilla
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Country [123]
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Spain
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State/province [123]
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Valencia
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Country [124]
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Sweden
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State/province [124]
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Solna
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Country [125]
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Sweden
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State/province [125]
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Uppsala
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Country [126]
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Taiwan
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State/province [126]
0
0
Hsin Chu
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Country [127]
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0
Taiwan
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State/province [127]
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Tainan
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Country [128]
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Taiwan
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State/province [128]
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Taoyuan
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Country [129]
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Thailand
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State/province [129]
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Bangkok
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Country [130]
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Thailand
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State/province [130]
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Chiangmai
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Country [131]
0
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Turkey
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State/province [131]
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Adana
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Country [132]
0
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Turkey
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State/province [132]
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Ankara
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Country [133]
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Turkey
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State/province [133]
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Antalya
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Country [134]
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Turkey
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State/province [134]
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Bursa
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Country [135]
0
0
Turkey
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State/province [135]
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Istanbul
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Country [136]
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Turkey
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State/province [136]
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Konya
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Country [137]
0
0
Ukraine
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State/province [137]
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0
Cherkasy
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Country [138]
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Ukraine
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State/province [138]
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Kharkiv
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Country [139]
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0
Ukraine
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State/province [139]
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0
Khmelnytsky
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Country [140]
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Ukraine
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State/province [140]
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0
Kryvyi Rih
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Country [141]
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0
Ukraine
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State/province [141]
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Kyiv
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Country [142]
0
0
Ukraine
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State/province [142]
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Lutsk
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Country [143]
0
0
Ukraine
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State/province [143]
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Odessa
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Country [144]
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0
Ukraine
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State/province [144]
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0
Poltava
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Country [145]
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0
Ukraine
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State/province [145]
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0
Ternopil
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Country [146]
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0
Ukraine
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State/province [146]
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0
Vinnytsia
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Country [147]
0
0
Ukraine
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State/province [147]
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0
Zaporizhzhya
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Country [148]
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0
United Kingdom
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State/province [148]
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0
Barnet
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Country [149]
0
0
United Kingdom
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State/province [149]
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0
Bradford
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Country [150]
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0
United Kingdom
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State/province [150]
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0
Coventry
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Country [151]
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0
United Kingdom
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State/province [151]
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Leeds
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Country [152]
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0
United Kingdom
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State/province [152]
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0
Manchester
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Country [153]
0
0
United Kingdom
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State/province [153]
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0
Newcastle
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Country [154]
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0
United Kingdom
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State/province [154]
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0
Stoke on Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants
with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms
and inflammation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04929210
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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0
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Phone
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
Study Contact
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Address
0
0
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Country
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0
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Phone
0
0
844-434-4210
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04929210
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