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

PHASE3CompletedINTERVENTIONAL
Enrollment

730

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

October 31, 2008

Conditions
Chronic Plaque Psoriasis
Interventions
BIOLOGICAL

adalimumab

subcutaneous injection using prefilled pen/syringe, solution containing 40 mg in 0.8 milliliters; 2 injections given at Baseline (Day 1) then once every other week from Weeks 1 though 15

DRUG

Calcipotriol/Betamethasone Ointment

Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16

DRUG

placebo (vehicle ointment)

Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16

Trial Locations (131)

1030

Vienna

1070

Brussels

1090

Vienna

Brussels

1160

Wein

1200

Brussels

1211

Geneva

2400

Copenhagen

2440

Geel

2650

Edegem

2900

Hellerup

3000

Leuven

3010

Bern

4000

Liège

4031

Basel

5020

Salzburg

6020

Innsbruck

7000

Mons

7400

Herning

8000

Bruges

Arhus C

8036

Graz

8091

Zurich

8500

Kortrijk

9000

Ghent

9300

Aalst

10117

Berlin

10827

Berlin

11000

Prague

14480

Potsdam

15700

Santiago

15706

Santiago de Compostela

15850

Lahti

16045

Bursa

16121

Athens

17176

Stockholm

18012

Granada

18055

Rostock

20161

Milan

20246

Hamburg

20354

Hamburg

20502

Malmo

21244

Buchholz Nordheide

24150

Kiel

26133

Oldenburg

28006

Madrid

28034

Madrid

28041

Madrid

28046

Madrid

29071

Málaga

29609

Brest

30449

Hanover

31059

Toulouse

33604

Pessac

34098

Istanbul

34295

Montpellier

34390

Çapa

34668

Istanbul

35010

Las Palmas de Gran Canarias

35128

Padua

36024

Vigo

37075

Göttingen

39008

Santander

39120

Magdeburg

40225

Düsseldorf

40620

Jyväskylä

41009

Seville

41100

Modena

41345

Gothenburg

42055

Saint-Etienne

46009

Valencia

46014

Valencia

48013

Bilbao

48149

Münster

48903

Bilbao

48960

Galdacano Vizcaya

49078

Osnabrück

50119

Florence

50924

Cologne

54000

Nancy

55101

Mainz

59037

Lille

60590

Frankfurt

65691

Brno

67100

Coppitto-L'Aquila

69115

Heidelberg

69310

Pierre-Bénite

71201

Crete

72076

Tübingen

75475

Paris

76031

Rouen

79104

Freiburg im Breisgau

79182

Falun

80337

München

82100

Benevento

87042

Limoges

88100

Catanzaro

90127

Palermo

91052

Erlangen

93053

Regensburg

94010

Créteil

95124

Catania

98200

Messina

500 05

Hradec Králové

00029

Helsinki HUS

06202

Nice

01067

Dresden

01307

Dresden

06097

Halle

07740

Jena

04103

Leipzig

0133

Roma

1105 AZ

Amsterdam

4818 CK

Breda

6229 HX

Maastricht

6525 GL

Nijmegen

3015 CA

Rotterdam

03010

Alicante

08025

Barcelona

08036

Barcelona

08916

Barcelona

06100

Ankara

06500

Ankara

AB25 2ZR

Aberdeen

CF14 4XN

Cardiff

G11 6NT

Glasgow

LS1 3EX

Leeds

NW3 2QG

London

M6 8HD

Manchester

NP20 4SZ

Newport Gwent

CV10 7DJ

Nuneaton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY