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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

Page last updated: August 23, 2015

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