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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/NCT03517722
Registration number
NCT03517722
Ethics application status
Date submitted
13/04/2018
Date registered
7/05/2018
Date last updated
2/02/2023
Titles & IDs
Public title
A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
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Secondary ID [1]
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0
2017-001489-53
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Secondary ID [2]
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CR108440
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ustekinumab (approximately 6 mg/kg)
Treatment: Drugs - Ustekinumab 90 mg
Experimental: Ustekinumab - Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160.
Experimental: Placebo - Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.
Treatment: Drugs: Placebo
Participants will receive placebo matching to ustekinumab IV or SC.
Treatment: Drugs: Ustekinumab (approximately 6 mg/kg)
Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
Treatment: Drugs: Ustekinumab 90 mg
Participants will receive 90 mg ustekinumab via SC route.
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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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Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Composite Response at Week 52
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Assessment method [1]
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SRI-4 response:>=4-point reduction in SLEDAI-2K total score, no British Isles Lupus Assessment Group (BILAG) A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in Physician's Global Assessment(PGA).SLEDAI measures disease activity in 9 organ systems,higher scores=more severe disease activity.Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Time to First Flare
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Assessment method [1]
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Time to flare is defined as the time (in days) post baseline when the first flare occurs. It was calculated with flare defined as either 1 or more BILAG A (severe disease activity) or 2 or more new BILAG B (moderate disease activity) domain scores relative to baseline. BILAG was defined as a measure of alterations or intensification to therapy consisting of 97 questions in 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. BILAG A flare was defined as at least 1 new BILAG A scores. BILAG B flare was defined as at least 2 new BILAG B scores.
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Timepoint [1]
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Up to Week 52
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Secondary outcome [2]
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Percentage of Participants With an SRI-4 Composite Response at Week 24
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Assessment method [2]
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SRI-4 response:>=4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no BILAG A (severe disease) and no more than 1 new BILAG B (moderate disease) domain score and no worsening (<10 % increase)from baseline in PGA.SLEDAI measures disease activity in 9 organ systems, higher scores=more severe disease activity. Each organ system measured as either absent/present within last 30 days and weighted score across systems was utilized to calculate total SLEDAI score(range:0=no symptoms to 105=presence of all defined symptoms). Improvement is defined as reduction in SLEDAI score (BILAG) Index: assessing clinical signs, symptoms,or laboratory parameters related to SLE,divided into 9 domains. Each domain can range from A=new domain activity, B=worse domain activity, C=same domain activity, D=improving domain activity to E=absence of domain activity. PGA assesses disease activity on visual analogue scale from very well(0)-very poor(10).
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Participants With 50 Percent (%) Improvement in Joints With Pain and Signs of Inflammation (Active Joints) at Week 52
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Assessment method [3]
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The percentage of participants who achieved at least 50% improvement from baseline in number of joints with pain and signs of inflammation at Week 52 for participants with at least 4 joints with pain and signs of inflammation at baseline were reported.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40 and Sustain That Change Through Week 52
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Assessment method [4]
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Reduction of glucocorticoid dose was defined as a reduction in average daily oral glucocorticoid dose by at least 50% (relative to the baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to the baseline dose) so that the average daily dose was reduced to less than or equal to (<=) 7.5 milligram (mg) (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who, at baseline, were receiving oral glucocorticoids.
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Timepoint [4]
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Up to Week 52
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Secondary outcome [5]
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Percentage of Participants With at Least a 50% Improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 52
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Assessment method [5]
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Percentage of participants achieving at least 50% improvement in CLASI activity score at Week 52 reported in participants with a CLASI activity score of 4 or greater at baseline. The CLASI is an instrument to assess the disease activity and damage caused to the skin for cutaneous lupus erythematosus participants with or without systemic involvement. The CLASI activity score ranges from 0-70 with lower score being improved. Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss, and non-scarring alopecia.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Percentage of Participants Receiving Glucocorticoid at Baseline Who Achieved Change in Glucocorticoid Dose by Week 40, Sustained That Change Through Week 52, and Achieved an SRI-4 Composite Response at Week 52
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Assessment method [6]
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Percentage of participants with reduction in glucocorticoid dose by Week 40, its sustenance through Week 52, and SRI 4 composite response at Week 52 were reported. Reduction of glucocorticoid dose was defined as reduction in average daily oral glucocorticoid dose by at least 50% (relative to baseline dose) or reduction of average daily oral glucocorticoid dose by at least 25% (relative to baseline dose) so that average daily dose is reduced to <=7.5 mg (prednisone or equivalent). Sustained reduction of glucocorticoid dose was defined as achieving an average daily oral glucocorticoid dose reduction between Weeks 24 and 40, and sustaining that reduction through Week 52, in those participants who,at baseline,were receiving oral glucocorticoids. SRI-4 was defined as composite of at least 4-point improvement in SLEDAI-2K score of 0=no symptoms to 105=presence of all defined symptoms with higher scores representing increased disease activity),no worsening in BILAG and no worsening in PGA.
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Timepoint [6]
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Up to Week 52
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Eligibility
Key inclusion criteria
- Be male or female
- Has a documented medical history (that is, met at least 1 of the two criteria below)
that participant met the Systemic Lupus International Collaborating Clinics (SLICC)
classification criteria for systemic lupus erythematosus (SLE) at least 3 months prior
to first dose of study agent:
1. Met a total of at least 4 SLICC criteria, including at least 1 clinical and at
least 1 immunologic;
2. Has a diagnosis of lupus nephritis, confirmed by renal biopsy and at least 1 of
the following autoantibodies: antinuclear antibodies (ANA) or
anti-double-stranded deoxyribonucleic acid (anti-dsDNA)
- Has a positive test in the medical history and confirmed at screening for at least 1
of the following autoantibodies: antinuclear antibodies, anti-double-stranded
deoxyribonucleic acid, and/or anti-Smith
- Has greater than or equal to (>=) 1 British Isles Lupus Assessment Group (BILAG) A
and/or >= 2 BILAG B scores observed during screening
- Has a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity
score >=4 (excluding diffuse non-inflammatory alopecia) or >= 4 joints with pain and
signs of inflammation at screening, Week 0, or both
- Has a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score >=6
at screening. Must also have SLEDAI-2K >= 4 for clinical features (excluding headache
and laboratory abnormalities) at Week 0
- Cannot be pregnant, nursing, intending to become pregnant, or unwilling to follow
contraception or egg/sperm donation guidelines
- Must be receiving stable doses of >=1 protocol-permitted standard of care SLE
treatment: oral glucocorticoids, anti-malarials, immunomodulators (methotrexate,
azathioprine, 6-mercaptopurine, mycophenolate mofetil, mycophenolic acid)
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Minimum age
16
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Maximum age
75
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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 any unstable or progressive SLE manifestation (example: central nervous system
lupus, systemic vasculitis, end-stage renal disease, severe or rapidly progressive
glomerulonephritis, pulmonary hemorrhage, myocarditis) that may warrant escalation in
therapy beyond permitted background medications. Participants requiring renal
hemodialysis or peritoneal dialysis are also excluded
- Has other co-existent inflammatory diseases (example: rheumatoid arthritis, psoriasis,
psoriatic arthritis, Crohn's disease)
- Has a urinary protein to creatinine ratio of greater than (>)4 gram per gram (g/g) per
day
- Has an acute or chronic infectious illness (example: human immunodeficiency virus,
hepatitis B or C virus, tuberculosis, opportunistic infections)
- Has a history of cancer or lymphoproliferative disease within the last 5 years except
for treated and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma,
or cervical carcinoma
- Has any condition requiring multiple courses of systemic glucocorticoids (example:
uncontrolled asthma, chronic obstructive pulmonary disease)
- Has a history of major surgery within the last month
- Has received live virus or bacterial vaccines within 16 weeks prior to first dose of
study agent or Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
- Has previously received ustekinumab
- Has received cyclophosphamide orally within 90 days or intravenously within 180 days
of screening
- Has received a single B-cell targeted therapy (e.g. belimumab) within 3 months, >1
previous B-cell targeted therapy within 6 months, or B-cell depleting therapy
(example: rituximab) within 12 months of first dose of study agent
- Has received protocol-prohibited oral or biologic immunomodulatory therapy in the last
3 months or less than (<)5 half-lives (whichever is longer) prior to first dose of
study agent
- Has received adrenocorticotropic hormone (ACTH) within 1 month prior to first dose of
study agent
- Has received epidural, intravenous, intramuscular, intraarticular, intrabursal,
intralesional glucocorticoids within 6 weeks of first dose of study agent
- Locally-delivered therapies except for ophthalmic use of cyclosporine A or topical use
of nonsteroidal anti inflammatory drugs (NSAIDs), analgesics, or high-potency
glucocorticoids (World Health Organization criteria) are prohibited
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
16/04/2018
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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
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Actual
5/11/2020
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Sample size
Target
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Accrual to date
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Final
516
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Recruitment in Australia
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Poland
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Nowa Sol
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Sonoswiec
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Tychy
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Warszawa
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Portugal
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Portugal
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Russian Federation
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Russian Federation
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St. Petersburg
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Russian Federation
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St.-Petersburg
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Russian Federation
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Ulyanovsk
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Kragujevac
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Serbia
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George
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Pretoria
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Stellenbosch
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Kaohsiung
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Bangkok
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Hat Yai
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Thailand
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Muang
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Ukraine
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Kharkiv
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Kyiv
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Odesa
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Ukraine
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Odessa
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Ukraine
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Vinnytsia
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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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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03517722
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/ct2/show/NCT03517722
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