Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00574249

Purpose

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.

Condition	Intervention	Phase
Chronic Plaque Psoriasis	Drug: adalimumab Drug: Calcipotriol + Betamethasone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Calcipotriene Adalimumab Bentelan Betamethasone Betamethasone dipropionate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

PASI 75 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety parameters [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
DLQI [ Time Frame: Change from Baseline in DLQI total score at weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
PASI [ Time Frame: Subjects who achieve PASI 50, 90 and 100 ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: Weeks 8 and 16 ] [ Designated as safety issue: No ]

Enrollment:	730
Study Start Date:	November 2007
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: adalimumab Soft Capsule (sc) Drug: Calcipotriol + Betamethasone Topical
2: Placebo Comparator	Drug: adalimumab Soft Capsule (sc) Drug: Calcipotriol + Betamethasone Topical

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574249

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Locations

Austria

Innsbruck, Austria, 6020

Salzburg, Austria, 5020

Wein, Austria, 1160

Wien, Austria, 1090

Graz, Austria, 8036

Wien, Austria, 1030
Belgium

Geel, Belgium, 2440

Aalst, Belgium, 9300

Brussel, Belgium, 1090

Liege, Belgium, 4000

Gent, Belgium, 9000

Mons, Belgium, 7000

Bruxelles, Belgium, 1200

Bruxelles, Belgium, 1070

Edegem, Belgium, 2650

Brugge, Belgium, 8000

Leuven, Belgium, 3000

Kortrijk, Belgium, 8500
Czech Republic

Prague, Czech Republic, 11000

Hradec Kralove, Czech Republic, 500 05

Brno, Czech Republic, 65691
Denmark

Copenhagen, Denmark, 2400

Arhus C, Denmark, 8000

Herning, Denmark, 7400

Hellerup, Denmark, 2900
Finland

Jyvaskyla, Finland, 40620

Lahti, Finland, 15850
Finland, HUS

Helsinki, HUS, Finland, 00029
France

Lille Cedex, France, 59037

Pierre Benite Cedex, France, 69310

Nancy, France, 54000

Pessac, France, 33604
France, Cedex

Creteil, Cedex, France, 94010

Limoges, Cedex, France, 87042

Rouen, Cedex, France, 76031

Brest, Cedex, France, 29609
France, Cedex 10

Paris, Cedex 10, France, 75475
France, Cedex 2

St Etienne, Cedex 2, France, 42055
France, Cedex 3

Nice, Cedex 3, France, 06202
France, Cedex 5

Montpellier, Cedex 5, France, 34295
France, Cedex 9

Toulouse, Cedex 9, France, 31059
Germany

Hamburg, Germany, 20246

Jena, Germany, 07740

Heidelberg, Germany, 69115

Magdeburg, Germany, 39120

Rostock, Germany, 18055

Koln, Germany, 50924

Oldenburg, Germany, 26133

Dusseldorf, Germany, 40225

Hannover, Germany, 30449

Munster, Germany, 48149

Gottingen, Germany, 37075

Kiel, Germany, 24150

Berlin, Germany, 10117

Munchen, Germany, 80337

Hamburg, Germany, 20354

Tubingen, Germany, 72076

Freiburg, Germany, 79104

Mainz, Germany, 55101

Berlin, Germany, 10827

Leipzig, Germany, 04103

Erlangen, Germany, 91052

Regensburg, Germany, 93053

Frankfurt, Germany, 60590

Potsdam, Germany, 14480

Dresden, Germany, 01067

Dresden, Germany, 01307

Osnabruck, Germany, 49078
Germany, Nordheide

Buchholz, Nordheide, Germany, 21244
Germany, Saale

Halle, Saale, Germany, 06097
Greece

Athens, Greece, 16121

Crete, Greece, 71201
Italy

Milano, Italy, 20161

Palermo, Italy, 90127

Messina, Italy, 98200

Benevento, Italy, 82100

Modena, Italy, 41100

Firenze, Italy, 50119

Catania, Italy, 95124

Coppitto-L'Aquila, Italy, 67100

Padova, Italy, 35128

Roma, Italy, 0133

Catanzaro, Italy, 88100
Netherlands

Breda, Netherlands, 4818 CK

Amsterdam, Netherlands, 1105 AZ

Maastricht, Netherlands, 6229 HX

Rotterdam, Netherlands, 3015 CA

Nijmegen, Netherlands, 6525 GL
Spain

Barcelona, Spain, 08036

Alicante, Spain, 03010

Madrid, Spain, 28034

Bilbao, Spain, 48013

Las Palmas de Gran Canarias, Spain, 35010

Madrid, Spain, 28046

Bilbao, Spain, 48903

Santander, Spain, 39008

Barcelona, Spain, 08916

Seville, Spain, 41009

Malaga, Spain, 29071

Madrid, Spain, 28006

Barcelona, Spain, 08025

Valencia, Spain, 46009

Valencia, Spain, 46014

Vigo, Spain, 36024

Madrid, Spain, 28041

Santiago de Compostela, Spain, 15706

Santiago, Spain, 15700

Granada, Spain, 18012
Spain, Vizcaya

Galdacano, Vizcaya, Spain, 48960
Sweden

Goteborg, Sweden, 41345

Falun, Sweden, 79182

Malmo, Sweden, 20502

Stockholm, Sweden, 17176
Switzerland

Basel, Switzerland, 4031

Geneva, Switzerland, 1211

Zurich, Switzerland, 8091

Bern, Switzerland, 3010
Turkey

Ankara, Turkey, 06100

Bursa, Turkey, 16045

Capa, Turkey, 34390

Ankara, Turkey, 06500

Istanbul, Turkey, 34098

Istanbul, Turkey, 34668
United Kingdom

Cardiff, United Kingdom, CF14 4XN

Leeds, United Kingdom, LS1 3EX

Manchester, United Kingdom, M6 8HD

Aberdeen, United Kingdom, AB25 2ZR

London, United Kingdom, NW3 2QG

Glasgow, United Kingdom, G11 6NT

Nuneaton, United Kingdom, CV10 7DJ
United Kingdom, Gwent

Newport, Gwent, United Kingdom, NP20 4SZ

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Marie Rosenfeld, Senior CRM )
Study ID Numbers:	M10-060
Study First Received:	December 12, 2007
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00574249 History of Changes
Health Authority:	Turkey: Ethics Committee

Keywords provided by Abbott:

Psoriasis
Moderate Psoriasis
Severe Psoriasis
Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis

Additional relevant MeSH terms:

Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Respiratory System Agents
Skin Diseases
Betamethasone sodium phosphate
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Adalimumab
Hormones

Glucocorticoids
Pharmacologic Actions
Calcipotriene
Psoriasis
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous
Betamethasone

ClinicalTrials.gov processed this record on November 27, 2009