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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05767034
Registration number
NCT05767034
Ethics application status
Date submitted
6/03/2023
Date registered
14/03/2023
Titles & IDs
Public title
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
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Scientific title
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
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Secondary ID [1]
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2022-501895-25-00
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Secondary ID [2]
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CAIN457C22301
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Universal Trial Number (UTN)
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Trial acronym
REPLENISH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polymyalgia Rheumatica
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Condition category
Condition code
Musculoskeletal
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Other neurological disorders
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Inflammatory and Immune System
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0
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab 300 mg
Treatment: Drugs - Secukinumab 150 mg
Other interventions - Placebo to secukinumab
Experimental: Secukinumab 300 mg - randomized in 1:1:1 ratio every 4 weeks
Experimental: Secukinumab 150 mg - randomized in 1:1:1 ratio every 4 weeks
Placebo comparator: Placebo to secukinumab - randomized in 1:1:1 ratio every 4 weeks
Treatment: Drugs: Secukinumab 300 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Treatment: Drugs: Secukinumab 150 mg
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
Other interventions: Placebo to secukinumab
Taken subcutaneously every 4 weeks until Week 48 in combination with a 24-week prednisone taper regimen
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Proportion of participants achieving sustained remission
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Assessment method [1]
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Sustained remission at Week 52 is defined as a participant meeting all of the following:
? achieved remission at Week 12
AND all of the following, sustained from Week 12 to Week 52:
* no recurrence of signs or symptoms, attributable to PMR, that requires escape treatment or rescue treatment
* no new diagnosis of Giant cell arteritis (GCA), that requires escape treatment or rescue treatment
Remission at Week 12 is defined as a participant meeting all of the following at Week 12:
* no use of escape treatment or rescue treatment prior to Week 12
* no signs or symptoms attributable to PMR, that requires escape treatment or use of rescue treatment, at Week 12
* no new diagnosis of GCA, that requires escape treatment or rescue treatment, at Week 12
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Timepoint [1]
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at Week 52
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Secondary outcome [1]
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Proportion of patients achieving complete sustained remission
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Assessment method [1]
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Complete sustained remission at Week 52 is defined as participant meeting all of the following:
* achieved sustained remission
* no clinically relevant elevation of Erythrocyte sedimentation Rate (ESR) and/or C-reactive protein (CRP) at =2 consecutive scheduled visits from Week 12 to Week 52
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Timepoint [1]
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52 Weeks
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Secondary outcome [2]
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Adjusted annual cumulative glucocorticoid (GC) dose adjusted by duration of study follow-up
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Assessment method [2]
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Adjusted annual cumulative GC dose is cumulative GC dose through Week 52 adjusted by duration of study follow-up
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Timepoint [2]
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52 Weeks
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Secondary outcome [3]
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Time to first use of escape treatment or rescue treatment as measured in days
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Assessment method [3]
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First use of escape treatment or rescue treatment is defined as the first time when the escape treatment or rescue treatment is used
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Timepoint [3]
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52 Weeks
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Secondary outcome [4]
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Change in FACIT-Fatigue Score
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Assessment method [4]
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The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function.
The purpose of collecting available FACIT-Fatigue data is to assess the impact of fatigue on participants with PMR.
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Timepoint [4]
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52 Weeks
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Secondary outcome [5]
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Change in HAQ-DI score
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Assessment method [5]
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The Health Assessment Questionnaire - Disability Index (HAQ-DI) is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The purpose of the HAQ-DI is to assess the functional ability of subjects with PMR.
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Timepoint [5]
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52 Weeks
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Eligibility
Key inclusion criteria
* Signed informed consent must be obtained prior to participation in the study
* Male or non-pregnant, non-lactating female participants at least 50 years of age.
* Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants = 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (= 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
* Morning stiffness > 45 minutes (min) (2 points)
* Hip pain or restricted range of motion (1 point)
* Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
* Absence of other joint involvement (1 point)
* Participants must have a history of being treated for at least 8 consecutive weeks with prednisone = 10 mg/day, or equivalent dose of another GC at any time prior to screening
* Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is = 5 mg/day (or equivalent dose of another GC) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following:
* Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of PMR relapse (such as constitutional symptoms) within 12 weeks prior to BSL that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia.
* Elevated ESR (= 30 mm/hr) and/or elevated CRP (> upper limit of normal (ULN)) attributable to PMR at the time of relapse and/or at screening
* Participants must have been treated as per local treatment recommendations following the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 25 mg/day at screening and during the screening period
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Minimum age
50
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
* Evidence/history of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result
* Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis
* Concurrent diagnosis or history of neuropathic muscular diseases or fibromyalgia
* Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment)
* Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
* Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within 12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who did not respond to or experienced a relapse during treatment are excluded from enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply
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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 administering the treatment/s
The people assessing the outcomes
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
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
22/03/2023
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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
17/02/2026
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Actual
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Westmead
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2145 - Westmead
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4215 - Southport
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7000 - Hobart
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3081 - Heidelberg Heights
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6100 - Victoria Park
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2150 - Parramatta
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Yamanashi
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Japan
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Okayama
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Lebanon
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Ashrafieh
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Lebanon
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Beirut
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Lebanon
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Saida
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Mexico
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Jalisco
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Mexico
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Sinaloa
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Netherlands
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Almelo
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Netherlands
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State/province [115]
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Groningen
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Netherlands
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Rotterdam
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Norway
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Tromsø
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Poland
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Bytom
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Poland
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Lublin
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Poland
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Warszawa
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South Africa
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Cape Town
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South Africa
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Panorama
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South Africa
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Stellenbosch
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Spain
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Spain
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Barcelona
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Pais Vasco
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Spain
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Madrid
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Sweden
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SE
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Switzerland
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Basel
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Switzerland
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Fribourg
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Switzerland
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St Gallen
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Turkey
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Cankaya
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Turkey
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Istanbul
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Turkey
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Kocaeli
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United Kingdom
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Wirral
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United Kingdom
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Barnet
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United Kingdom
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Edinburgh
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United Kingdom
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Hull
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
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Trial website
https://clinicaltrials.gov/study/NCT05767034
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for public queries
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Novartis Pharmaceuticals
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Phone
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1-888-669-6682
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05767034