Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Graz, 8036 | Status Not Available | |
Location Innsbruck, 6020 | Status Not Available | |
Location Salzburg, 5020 | Status Not Available | |
Location Wein, 1160 | Status Not Available | |
Location Wien, 1030 | Status Not Available | |
Location Wien, 1090 | Status Not Available | |
Location Aalst, 9300 | Status Not Available | |
Location Brugge, 8000 | Status Not Available | |
Location Brussel, 1090 | Status Not Available | |
Location Bruxelles, 1070 | Status Not Available | |
Location Bruxelles, 1200 | Status Not Available | |
Location Edegem, 2650 | Status Not Available | |
Location Geel, 2440 | Status Not Available | |
Location Gent, 9000 | Status Not Available | |
Location Kortrijk, 8500 | Status Not Available | |
Location Leuven, 3000 | Status Not Available | |
Location Liege, 4000 | Status Not Available | |
Location Mons, 7000 | Status Not Available | |
Location Brno, 65691 | Status Not Available | |
Location Hradec Kralove, 500 05 | Status Not Available | |
Location Prague, 11000 | Status Not Available | |
Location Arhus C, 8000 | Status Not Available | |
Location Copenhagen, 2400 | Status Not Available | |
Location Hellerup, 2900 | Status Not Available | |
Location Herning, 7400 | Status Not Available | |
Location Helsinki HUS, 00029 | Status Not Available | |
Location Jyvaskyla, 40620 | Status Not Available | |
Location Lahti, 15850 | Status Not Available | |
Location Brest Cedex, 29609 | Status Not Available | |
Location Creteil Cedex, 94010 | Status Not Available | |
Location Lille Cedex, 59037 | Status Not Available | |
Location Limoges Cedex, 87042 | Status Not Available | |
Location Montpellier Cedex 5, 34295 | Status Not Available | |
Location Nancy, 54000 | Status Not Available | |
Location Nice Cedex 3, 06202 | Status Not Available | |
Location Paris Cedex 10, 75475 | Status Not Available | |
Location Pessac, 33604 | Status Not Available | |
Location Pierre Benite Cedex, 69310 | Status Not Available | |
Location Rouen, 76031 | Status Not Available | |
Location St Etienne Cedex 2, 42055 | Status Not Available | |
Location Toulouse Cedex 9, 31059 | Status Not Available | |
Location Berlin, 10117 | Status Not Available | |
Location Berlin, 10827 | Status Not Available | |
Location Buchholz Nordheide, 21244 | Status Not Available | |
Location Dresden, 01067 | Status Not Available | |
Location Dresden, 01307 | Status Not Available | |
Location Dusseldorf, 40225 | Status Not Available | |
Location Erlangen, 91052 | Status Not Available | |
Location Frankfurt, 60590 | Status Not Available | |
Location Freiburg, 79104 | Status Not Available | |
Location Gottingen, 37075 | Status Not Available | |
Location Halle Saale, 06097 | Status Not Available | |
Location Hamburg, 20246 | Status Not Available | |
Location Hamburg, 20354 | Status Not Available | |
Location Hannover, 30449 | Status Not Available | |
Location Heidelberg, 69115 | Status Not Available | |
Location Jena, 07740 | Status Not Available | |
Location Kiel, 24150 | Status Not Available | |
Location Koln, 50924 | Status Not Available | |
Location Leipzig, 04103 | Status Not Available | |
Location Magdeburg, 39120 | Status Not Available | |
Location Mainz, 55101 | Status Not Available | |
Location Munchen, 80337 | Status Not Available | |
Location Munster, 48149 | Status Not Available | |
Location Oldenburg, 26133 | Status Not Available | |
Location Osnabruck, 49078 | Status Not Available | |
Location Potsdam, 14480 | Status Not Available | |
Location Regensburg, 93053 | Status Not Available | |
Location Rostock, 18055 | Status Not Available | |
Location Tubingen, 72076 | Status Not Available | |
Location Athens, 16121 | Status Not Available | |
Location Crete, 71201 | Status Not Available | |
Location Benevento, 82100 | Status Not Available | |
Location Catania, 95124 | Status Not Available | |
Location Catanzaro, 88100 | Status Not Available | |
Location Coppitto-L'Aquila, 67100 | Status Not Available | |
Location Firenze, 50119 | Status Not Available | |
Location Messina, 98200 | Status Not Available | |
Location Milano, 20161 | Status Not Available | |
Location Modena, 41100 | Status Not Available | |
Location Padova, 35128 | Status Not Available | |
Location Palermo, 90127 | Status Not Available | |
Location Roma, 0133 | Status Not Available | |
Location Amsterdam, 1105 AZ | Status Not Available | |
Location Breda, 4818 CK | Status Not Available | |
Location Maastricht, 6229 HX | Status Not Available | |
Location Nijmegen, 6525 GL | Status Not Available | |
Location Rotterdam, 3015 CA | Status Not Available | |
Location Alicante, 03010 | Status Not Available | |
Location Barcelona, 08025 | Status Not Available | |
Location Barcelona, 08036 | Status Not Available | |
Location Barcelona, 08916 | Status Not Available | |
Location Bilbao, 48013 | Status Not Available | |
Location Bilbao, 48903 | Status Not Available | |
Location Galdacano Vizcaya, 48960 | Status Not Available | |
Location Granada, 18012 | Status Not Available | |
Location Las Palmas de Gran Canarias, 35010 | Status Not Available | |
Location Madrid, 28006 | Status Not Available | |
Location Madrid, 28034 | Status Not Available | |
Location Madrid, 28041 | Status Not Available | |
Location Madrid, 28046 | Status Not Available | |
Location Malaga, 29071 | Status Not Available | |
Location Santander, 39008 | Status Not Available | |
Location Santiago de Compostela, 15706 | Status Not Available | |
Location Santiago, 15700 | Status Not Available | |
Location Seville, 41009 | Status Not Available | |
Location Valencia, 46009 | Status Not Available | |
Location Valencia, 46014 | Status Not Available | |
Location Vigo, 36024 | Status Not Available | |
Location Falun, 79182 | Status Not Available | |
Location Goteborg, 41345 | Status Not Available | |
Location Malmo, 20502 | Status Not Available | |
Location Stockholm, 17176 | Status Not Available | |
Location Basel, 4031 | Status Not Available | |
Location Bern, 3010 | Status Not Available | |
Location Geneva, 1211 | Status Not Available | |
Location Zurich, 8091 | Status Not Available | |
Location Ankara, 06100 | Status Not Available | |
Location Ankara, 06500 | Status Not Available | |
Location Bursa, 16045 | Status Not Available | |
Location Capa, 34390 | Status Not Available | |
Location Istanbul, 34098 | Status Not Available | |
Location Istanbul, 34668 | Status Not Available | |
Location Aberdeen, AB25 2ZR | Status Not Available | |
Location Cardiff, CF14 4XN | Status Not Available | |
Location Glasgow, G11 6NT | Status Not Available | |
Location Leeds, LS1 3EX | Status Not Available | |
Location London, NW3 2QG | Status Not Available | |
Location Manchester, M6 8HD | Status Not Available | |
Location Newport Gwent, NP20 4SZ | Status Not Available | |
Location Nuneaton, CV10 7DJ | Status Not Available |
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.
Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percentage of Participants With a PASI50 Response at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percentage of Participants With a PASI90 Response at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percentage of Participants With a PASI100 Response at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 2
Time Frame: Week 2
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 4
Time Frame: Week 4
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 8
Time Frame: Week 8
Percentage of Participants Achieving a Physician's Global Assessment (PGA) of Clear or Minimal at Week 12
Time Frame: Week 12
Percentage of Participants Achieving a Physicians Global Assessment (PGA) Response of Clear or Minimal at Week 16
Time Frame: Week 16
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percent Change in the Dermatology Life Quality Index (DLQI) Total Score at Week 2 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 2
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 4 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 4
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 8 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 8
Percent Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 12 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 12
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 16 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 16
Percent Change in Short Form 36 Health Survey (SF-36) Physical Component Score (PCS) at Week 8 Compared With Baseline (Week 0)
Time Frame: Week 0 and Week 8
Interventions:
- Biological: adalimumab
- Drug: Calcipotriol/Betamethasone Ointment
- Drug: placebo (vehicle ointment)
Enrollment:
730
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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