Novartis Pharmaceuticals
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2
Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis
secukinumab
placebo
PHASE3
TP1: All eligible subjects entered TP1 to receive 12-weeks of open-label secukinumab at a dose predicted to achieve secukinumab serum levels equivalent to adults administered a 150 mg dose regimen. Secukinumab was administered s.c. weekly for the first 4 weeks (Baseline, Weeks 1, 2, 3, 4) and then every 4 weeks thereafter. Clinical response (JIA ACR 30) was assessed at Week 12. Responders advanced to TP2 and non-responders exited the trial (early termination visit and entered into the Post-treatment follow-up period). TP2: Subjects who were a responder (JIA ACR 30) at Week 12 entered the double-blind withdrawal TP2 and were randomized 1:1 to either secukinumab or placebo on that visit and then every 4 weeks, until either experiencing a disease flare or completion of TP2. TP2 was event driven and was planned to be closed when 33 subjects experienced a disease flare as per JIA definition. Alternatively, the study could be closed when all subjects reached the total study duration of 104 Weeks and therefore subjects who did not experience a disease flare remained in TP2 for the duration of the study and completed the study without entering into TP3 TP3: Subjects experiencing a disease flare in TP2 immediately entered TP3 to receive openlabel secukinumab every 4 weeks until total study duration of 104 weeks for that subject was achieved. Post-treatment follow-up: The post-treatment follow-up period (lasting 12 weeks from the last study drug administration) was required for all subjects, unless they qualified and entered the secukinumab extension trial. All subjects were expected to participate in the post-treatment follow up period, except for those entering the extension study.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 86 participants |
Masking : | QUADRUPLE |
Primary Purpose : | TREATMENT |
Official Title : | A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis |
Actual Study Start Date : | 2017-05-23 |
Estimated Primary Completion Date : | 2020-10-07 |
Estimated Study Completion Date : | 2020-11-09 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 2 Years to 17 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Los Angeles, California, United States, 90027
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Boise, Idaho, United States, 83702
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Cincinnati, Ohio, United States, 45229
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Portland, Oregon, United States, 97232
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Bruxelles, Belgium, 1200
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Gent, Belgium, 9000
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Laeken, Belgium, 1020
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Berlin, Germany, 13353
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Freiburg, Germany, 79106
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Hamburg, Germany, 22081
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Saint Augustine, Germany, 53757
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Genova, GE, Italy, 16147
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Napoli, Italy, 80131
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Krakow, Poland, 31503
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Yekaterinburg, Russian Federation, 620149
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Moscow, Russian Federation, 119991
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Saint-Petersburg, Russian Federation, 194100
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Voronezh, Russian Federation, 394036
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Cape Town, South Africa, 7925
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Panorama, South Africa, 7500
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Santiago de Compostela, Galicia, Spain, 15706
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Valencia, Spain, 46026
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Istanbul, Cyclic, Turkey, 34303
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Istanbul, SHOULD, Turkey, 34098
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Ankara, Turkey, 06100
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Istanbul, Turkey, 34766
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Bristol, United Kingdom, BS2 8BJ
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Glasgow, United Kingdom, G51 4TF
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Liverpool, United Kingdom, L12 2AP
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London, United Kingdom, WC1N 3JH
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Nottingham, United Kingdom, NG7 2UH