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

Tracking Information
First Received Date ^ICMJE	December 12, 2007
Last Updated Date	March 17, 2009
Start Date ^ICMJE	November 2007
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 22, 2007)	PASI 75 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 12, 2007)	PASI 75 [ Time Frame: Week 16 ]
Change History	Complete list of historical versions of study NCT00574249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 14, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 12, 2007)	Safety parameters [ Time Frame: Throughout study ] PGA [ Time Frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at weeks 2, 4, 8, 12 and 16 ] DLQI [ Time Frame: Change from Baseline in DLQI total score at weeks 2, 4, 8, 12 and 16 ] PASI [ Time Frame: Subjects who achieve PASI 50, 90 and 100 ] SF-36 [ Time Frame: Weeks 8 and 16 ]

Descriptive Information
Brief Title ^ICMJE	Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
Official Title ^ICMJE	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
Brief 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.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Plaque Psoriasis
Intervention ^ICMJE	Drug: adalimumab Drug: Calcipotriol + Betamethasone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	730
Completion Date
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00574249
Responsible Party	Marie Rosenfeld, Senior CRM, Abbott
Study ID Numbers ^ICMJE	M10-060
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP