Clinical trial NCT00574249: Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Keywords: Psoriasis
Moderate Psoriasis
Severe Psoriasis
Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
measure: Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
measure: Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
timeFrame: Week 2
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
timeFrame: Week 4
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
timeFrame: Week 8
measure: Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
timeFrame: Week 12
measure: Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
timeFrame: Week 16
measure: Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
measure: Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 2
measure: Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 4
measure: Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 8
measure: Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 12
measure: Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 16
measure: Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
timeFrame: Week 0 and Week 8
Other outcomes:
measure: Percent Change in Psoriasis Scalp Severity Index (PSSI) From Baseline to Week 16.
timeFrame: Week 0 and Week 16
measure: Percent Change in Nail Psoriasis Severity Index (NAPSI) at Week 16.
timeFrame: Week 0 and Week 16
Locations:
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Salzburg
country: Austria
city: Wein
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Brugge
country: Belgium
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Geel
country: Belgium
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Mons
country: Belgium
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Prague
country: Czech Republic
city: Arhus C
country: Denmark
city: Copenhagen
country: Denmark
city: Hellerup
country: Denmark
city: Herning
country: Denmark
city: Helsinki HUS
country: Finland
city: Jyvaskyla
country: Finland
city: Lahti
country: Finland
city: Brest Cedex
country: France
city: Creteil Cedex
country: France
city: Lille Cedex
country: France
city: Limoges Cedex
country: France
city: Montpellier Cedex 5
country: France
city: Nancy
country: France
city: Nice Cedex 3
country: France
city: Paris Cedex 10
country: France
city: Pessac
country: France
city: Pierre Benite Cedex
country: France
city: Rouen
country: France
city: St Etienne Cedex 2
country: France
city: Toulouse Cedex 9
country: France
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Buchholz Nordheide
country: Germany
city: Dresden
country: Germany
city: Dresden
country: Germany
city: Dusseldorf
country: Germany
city: Erlangen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Gottingen
country: Germany
city: Halle Saale
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Mainz
country: Germany
city: Munchen
country: Germany
city: Munster
country: Germany
city: Oldenburg
country: Germany
city: Osnabruck
country: Germany
city: Potsdam
country: Germany
city: Regensburg
country: Germany
city: Rostock
country: Germany
city: Tubingen
country: Germany
city: Athens
country: Greece
city: Crete
country: Greece
city: Benevento
country: Italy
city: Catania
country: Italy
city: Catanzaro
country: Italy
city: Coppitto-L'Aquila
country: Italy
city: Firenze
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Bilbao
country: Spain
city: Galdacano Vizcaya
country: Spain
city: Granada
country: Spain
city: Las Palmas de Gran Canarias
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Santiago
country: Spain
city: Seville
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Vigo
country: Spain
city: Falun
country: Sweden
city: Goteborg
country: Sweden
city: Malmo
country: Sweden
city: Stockholm
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Zurich
country: Switzerland
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Bursa
country: Turkey
city: Capa
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Aberdeen
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newport Gwent
country: United Kingdom
city: Nuneaton
country: United Kingdom
Study officials:
References:
citation: 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.