Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Plaque Psoriasis
Intervention: adalimumab (Biological); Calcipotriol/Betamethasone Ointment (Drug); placebo (vehicle ointment) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott
Summary
The objective of this study is to assess the efficacy and safety of adalimumab in
combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in
combination with matching vehicle in subjects with moderate to severe chronic plaque
psoriasis.
Clinical Details
Official title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
Secondary outcome: Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0) Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0) Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2 Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4 Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8 Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12 Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16 Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0) Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0) Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0) Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0) Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0) Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0) Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
Detailed description:
Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member
states. Abbott US is sponsor for non-EU member states.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject is >= 18 years of age
- 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 has previous exposure to adalimumab
- 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
Locations and Contacts
Graz 8036, Austria
Innsbruck 6020, Austria
Salzburg 5020, Austria
Wein 1160, Austria
Wien 1090, Austria
Wien 1030, Austria
Aalst 9300, Belgium
Brugge 8000, Belgium
Brussel 1090, Belgium
Bruxelles 1200, Belgium
Bruxelles 1070, Belgium
Edegem 2650, Belgium
Geel 2440, Belgium
Gent 9000, Belgium
Kortrijk 8500, Belgium
Leuven 3000, Belgium
Liege 4000, Belgium
Mons 7000, Belgium
Brno 65691, Czech Republic
Hradec Kralove 500 05, Czech Republic
Prague 11000, Czech Republic
Arhus C 8000, Denmark
Copenhagen 2400, Denmark
Hellerup 2900, Denmark
Herning 7400, Denmark
Helsinki HUS 00029, Finland
Jyvaskyla 40620, Finland
Lahti 15850, Finland
Brest Cedex 29609, France
Creteil Cedex 94010, France
Lille Cedex 59037, France
Limoges Cedex 87042, France
Montpellier Cedex 5 34295, France
Nancy 54000, France
Nice Cedex 3 06202, France
Paris Cedex 10 75475, France
Pessac 33604, France
Pierre Benite Cedex 69310, France
Rouen 76031, France
St Etienne Cedex 2 42055, France
Toulouse Cedex 9 31059, France
Berlin 10117, Germany
Berlin 10827, Germany
Buchholz Nordheide 21244, Germany
Dresden 01067, Germany
Dresden 01307, Germany
Dusseldorf 40225, Germany
Erlangen 91052, Germany
Frankfurt 60590, Germany
Freiburg 79104, Germany
Gottingen 37075, Germany
Halle Saale 06097, Germany
Hamburg 20246, Germany
Hamburg 20354, Germany
Hannover 30449, Germany
Heidelberg 69115, Germany
Jena 07740, Germany
Kiel 24150, Germany
Koln 50924, Germany
Leipzig 04103, Germany
Magdeburg 39120, Germany
Mainz 55101, Germany
Munchen 80337, Germany
Munster 48149, Germany
Oldenburg 26133, Germany
Osnabruck 49078, Germany
Potsdam 14480, Germany
Regensburg 93053, Germany
Rostock 18055, Germany
Tubingen 72076, Germany
Athens 16121, Greece
Crete 71201, Greece
Benevento 82100, Italy
Catania 95124, Italy
Catanzaro 88100, Italy
Coppitto-L'Aquila 67100, Italy
Firenze 50119, Italy
Messina 98200, Italy
Milano 20161, Italy
Modena 41100, Italy
Padova 35128, Italy
Palermo 90127, Italy
Roma 0133, Italy
Amsterdam 1105 AZ, Netherlands
Breda 4818 CK, Netherlands
Maastricht 6229 HX, Netherlands
Nijmegen 6525 GL, Netherlands
Rotterdam 3015 CA, Netherlands
Alicante 03010, Spain
Barcelona 08025, Spain
Barcelona 08036, Spain
Barcelona 08916, Spain
Bilbao 48013, Spain
Bilbao 48903, Spain
Galdacano Vizcaya 48960, Spain
Granada 18012, Spain
Las Palmas de Gran Canarias 35010, Spain
Madrid 28046, Spain
Madrid 28034, Spain
Madrid 28041, Spain
Madrid 28006, Spain
Malaga 29071, Spain
Santander 39008, Spain
Santiago de Compostela 15706, Spain
Santiago 15700, Spain
Seville 41009, Spain
Valencia 46014, Spain
Valencia 46009, Spain
Vigo 36024, Spain
Falun 79182, Sweden
Goteborg 41345, Sweden
Malmo 20502, Sweden
Stockholm 17176, Sweden
Basel 4031, Switzerland
Bern 3010, Switzerland
Geneva 1211, Switzerland
Zurich 8091, Switzerland
Ankara 06100, Turkey
Ankara 06500, Turkey
Bursa 16045, Turkey
Capa 34390, Turkey
Istanbul 34668, Turkey
Istanbul 34098, Turkey
Aberdeen AB25 2ZR, United Kingdom
Cardiff CF14 4XN, United Kingdom
Glasgow G11 6NT, United Kingdom
Leeds LS1 3EX, United Kingdom
London NW3 2QG, United Kingdom
Manchester M6 8HD, United Kingdom
Newport Gwent NP20 4SZ, United Kingdom
Nuneaton CV10 7DJ, United Kingdom
Additional Information
Starting date: November 2007
Last updated: April 11, 2011
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