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

Last updated: April 11, 2011
Sponsor: Abbott
Overall Status: Completed

Phase

3

Condition

Warts

Rosacea

Psoriasis And Psoriatic Disorders

Treatment

N/A

Clinical Study ID

NCT00574249
M10-060
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 becyclosporine, or methotrexate or oral PUVA

  • Subject is judged to be in generally good health as determined by the principalinvestigator

Exclusion

Exclusion Criteria:

  • Subject has previous exposure to adalimumab

  • Subject cannot discontinue systemic therapies and/or topical therapies for thetreatment 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-inducedor 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

Study Design

Total Participants: 730
Study Start date:
November 01, 2007
Estimated Completion Date:

Study Description

Additional information regarding sponsors: Abbott GmbH & Co. KG is sponsor for EU member states. Abbott US is sponsor for non-EU member states.

Connect with a study center

  • Graz, 8036
    Austria

    Site Not Available

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Salzburg, 5020
    Austria

    Site Not Available

  • Wein, 1160
    Austria

    Site Not Available

  • Wien, 1030
    Austria

    Site Not Available

  • Aalst, 9300
    Belgium

    Site Not Available

  • Brugge, 8000
    Belgium

    Site Not Available

  • Brussel, 1090
    Belgium

    Site Not Available

  • Bruxelles, 1200
    Belgium

    Site Not Available

  • Edegem, 2650
    Belgium

    Site Not Available

  • Geel, 2440
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Kortrijk, 8500
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Liege, 4000
    Belgium

    Site Not Available

  • Mons, 7000
    Belgium

    Site Not Available

  • Brno, 65691
    Czech Republic

    Site Not Available

  • Hradec Kralove, 500 05
    Czech Republic

    Site Not Available

  • Prague, 11000
    Czech Republic

    Site Not Available

  • Arhus C, 8000
    Denmark

    Site Not Available

  • Copenhagen, 2400
    Denmark

    Site Not Available

  • Hellerup, 2900
    Denmark

    Site Not Available

  • Herning, 7400
    Denmark

    Site Not Available

  • Helsinki HUS, 00029
    Finland

    Site Not Available

  • Jyvaskyla, 40620
    Finland

    Site Not Available

  • Lahti, 15850
    Finland

    Site Not Available

  • Brest Cedex, 29609
    France

    Site Not Available

  • Creteil Cedex, 94010
    France

    Site Not Available

  • Lille Cedex, 59037
    France

    Site Not Available

  • Limoges Cedex, 87042
    France

    Site Not Available

  • Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Nancy, 54000
    France

    Site Not Available

  • Nice Cedex 3, 06202
    France

    Site Not Available

  • Paris Cedex 10, 75475
    France

    Site Not Available

  • Pessac, 33604
    France

    Site Not Available

  • Pierre Benite Cedex, 69310
    France

    Site Not Available

  • Rouen, 76031
    France

    Site Not Available

  • St Etienne Cedex 2, 42055
    France

    Site Not Available

  • Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Berlin, 10827
    Germany

    Site Not Available

  • Buchholz Nordheide, 21244
    Germany

    Site Not Available

  • Dresden, 01307
    Germany

    Site Not Available

  • Dusseldorf, 40225
    Germany

    Site Not Available

  • Erlangen, 91052
    Germany

    Site Not Available

  • Frankfurt, 60590
    Germany

    Site Not Available

  • Freiburg, 79104
    Germany

    Site Not Available

  • Gottingen, 37075
    Germany

    Site Not Available

  • Halle Saale, 06097
    Germany

    Site Not Available

  • Hamburg, 20246
    Germany

    Site Not Available

  • Hannover, 30449
    Germany

    Site Not Available

  • Heidelberg, 69115
    Germany

    Site Not Available

  • Jena, 07740
    Germany

    Site Not Available

  • Kiel, 24150
    Germany

    Site Not Available

  • Koln, 50924
    Germany

    Site Not Available

  • Leipzig, 04103
    Germany

    Site Not Available

  • Magdeburg, 39120
    Germany

    Site Not Available

  • Mainz, 55101
    Germany

    Site Not Available

  • Munchen, 80337
    Germany

    Site Not Available

  • Munster, 48149
    Germany

    Site Not Available

  • Oldenburg, 26133
    Germany

    Site Not Available

  • Osnabruck, 49078
    Germany

    Site Not Available

  • Potsdam, 14480
    Germany

    Site Not Available

  • Regensburg, 93053
    Germany

    Site Not Available

  • Rostock, 18055
    Germany

    Site Not Available

  • Tubingen, 72076
    Germany

    Site Not Available

  • Athens, 16121
    Greece

    Site Not Available

  • Crete, 71201
    Greece

    Site Not Available

  • Benevento, 82100
    Italy

    Site Not Available

  • Catania, 95124
    Italy

    Site Not Available

  • Catanzaro, 88100
    Italy

    Site Not Available

  • Coppitto-L'Aquila, 67100
    Italy

    Site Not Available

  • Firenze, 50119
    Italy

    Site Not Available

  • Messina, 98200
    Italy

    Site Not Available

  • Milano, 20161
    Italy

    Site Not Available

  • Modena, 41100
    Italy

    Site Not Available

  • Padova, 35128
    Italy

    Site Not Available

  • Palermo, 90127
    Italy

    Site Not Available

  • Roma, 0133
    Italy

    Site Not Available

  • Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Breda, 4818 CK
    Netherlands

    Site Not Available

  • Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Nijmegen, 6525 GL
    Netherlands

    Site Not Available

  • Rotterdam, 3015 CA
    Netherlands

    Site Not Available

  • Alicante, 03010
    Spain

    Site Not Available

  • Barcelona, 08036
    Spain

    Site Not Available

  • Bilbao, 48903
    Spain

    Site Not Available

  • Galdacano Vizcaya, 48960
    Spain

    Site Not Available

  • Granada, 18012
    Spain

    Site Not Available

  • Las Palmas de Gran Canarias, 35010
    Spain

    Site Not Available

  • Madrid, 28041
    Spain

    Site Not Available

  • Malaga, 29071
    Spain

    Site Not Available

  • Santander, 39008
    Spain

    Site Not Available

  • Santiago, 15700
    Spain

    Site Not Available

  • Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Seville, 41009
    Spain

    Site Not Available

  • Valencia, 46009
    Spain

    Site Not Available

  • Vigo, 36024
    Spain

    Site Not Available

  • Falun, 79182
    Sweden

    Site Not Available

  • Goteborg, 41345
    Sweden

    Site Not Available

  • Malmo, 20502
    Sweden

    Site Not Available

  • Stockholm, 17176
    Sweden

    Site Not Available

  • Basel, 4031
    Switzerland

    Site Not Available

  • Bern, 3010
    Switzerland

    Site Not Available

  • Geneva, 1211
    Switzerland

    Site Not Available

  • Zurich, 8091
    Switzerland

    Site Not Available

  • Ankara, 06100
    Turkey

    Site Not Available

  • Bursa, 16045
    Turkey

    Site Not Available

  • Capa, 34390
    Turkey

    Site Not Available

  • Istanbul, 34668
    Turkey

    Site Not Available

  • Aberdeen, AB25 2ZR
    United Kingdom

    Site Not Available

  • Cardiff, CF14 4XN
    United Kingdom

    Site Not Available

  • Glasgow, G11 6NT
    United Kingdom

    Site Not Available

  • Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • London, NW3 2QG
    United Kingdom

    Site Not Available

  • Manchester, M6 8HD
    United Kingdom

    Site Not Available

  • Newport Gwent, NP20 4SZ
    United Kingdom

    Site Not Available

  • Nuneaton, CV10 7DJ
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.