Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
NCT ID: NCT00574249
Last Updated: 2011-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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adalimumab + placebo
adalimumab + placebo (vehicle ointment)
adalimumab
subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
placebo (vehicle ointment)
Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
adalimumab + calcipotriol/betamethasone
adalimumab + calcipotriol/betamethasone ointment
adalimumab
subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
Calcipotriol/Betamethasone Ointment
Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
Interventions
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adalimumab
subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15
Calcipotriol/Betamethasone Ointment
Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
placebo (vehicle ointment)
Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
* Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
* Subject is judged to be in generally good health as determined by the principal investigator
Exclusion Criteria
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject is taking or requires oral or injectible corticosteroids
* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
* Subject has a calcium metabolism disorder
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Graz, , Austria
Innsbruck, , Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Wein, , Austria
Aalst, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Geel, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Mons, , Belgium
Brno, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Arhus C, , Denmark
Copenhagen, , Denmark
Hellerup, , Denmark
Herning, , Denmark
Helsinki HUS, , Finland
Jyväskylä, , Finland
Lahti, , Finland
Brest, , France
Créteil, , France
Lille, , France
Limoges, , France
Montpellier, , France
Nancy, , France
Nice, , France
Paris, , France
Pessac, , France
Pierre-Bénite, , France
Rouen, , France
Saint-Etienne, , France
Toulouse, , France
Berlin, , Germany
Berlin, , Germany
Buchholz Nordheide, , Germany
Cologne, , Germany
Dresden, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Halle, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Jena, , Germany
Kiel, , Germany
Leipzig, , Germany
Magdeburg, , Germany
Mainz, , Germany
München, , Germany
Münster, , Germany
Oldenburg, , Germany
Osnabrück, , Germany
Potsdam, , Germany
Regensburg, , Germany
Rostock, , Germany
Tübingen, , Germany
Athens, , Greece
Crete, , Greece
Benevento, , Italy
Catania, , Italy
Catanzaro, , Italy
Coppitto-L'Aquila, , Italy
Florence, , Italy
Messina, , Italy
Milan, , Italy
Modena, , Italy
Padua, , Italy
Palermo, , Italy
Roma, , Italy
Amsterdam, , Netherlands
Breda, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Alicante, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Bilbao, , Spain
Bilbao, , Spain
Galdacano Vizcaya, , Spain
Granada, , Spain
Las Palmas de Gran Canarias, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Santiago, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Valencia, , Spain
Vigo, , Spain
Falun, , Sweden
Gothenburg, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Basel, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Zurich, , Switzerland
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Çapa, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Aberdeen, , United Kingdom
Cardiff, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newport Gwent, , United Kingdom
Nuneaton, , United Kingdom
Countries
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References
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Paul C, van de Kerkhof P, Puig L, Unnebrink K, Goldblum O, Thaci D. Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. Eur J Dermatol. 2012 Nov-Dec;22(6):762-9. doi: 10.1684/ejd.2012.1863.
Other Identifiers
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M10-060
Identifier Type: -
Identifier Source: org_study_id
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