Trial NCT00512187

Property	Value
linkedct:arm_group	<http://data.linkedct.org/resource/arm_group/45310>
linkedct:brief_title	Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
linkedct:condition	<http://data.linkedct.org/resource/condition/2837>
linkedct:condition	<http://data.linkedct.org/resource/condition/9106>
linkedct:criteria	Inclusion Criteria: - 18 years of age,active but clinically stable plaque psoriasis involving at least 10 percent of the body surface area and a psoriasis area and severity index (PASI) score 10 and a body mass index 30. Exclusion Criteria: - Other type of psoriasis (guttate, erythrodermic and pustular psoriasis) - Uncontrolled hypertension - Severe congestive heart failure - Renal and liver impairment - Active or chronic infections, including HIV, HBV and HCV infections, latent tuberculosis - Previous or active malignancies - Pregnancy and lactations - Previous treatment with cyclosporine - Phototherapy or any systemic or topical therapy for psoriasis within the previous 4 weeks before enrolment.
linkedct:download_date	Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender	Both
linkedct:eligibility_healthy_volunteers	No
linkedct:eligibility_maximum_age	80 Years
linkedct:eligibility_minimum_age	18 Years
linkedct:end_date	August 2007
linkedct:enrollment	0 (xsd:int)
linkedct:firstreceived_date	August 6, 2007
linkedct:has_dmc	No
linkedct:id	NCT00512187
linkedct:intervention	<http://data.linkedct.org/resource/intervention/42253>
rdfs:label	Trial NCT00512187
linkedct:lastchanged_date	August 6, 2007
linkedct:lead_sponsor_agency	<http://data.linkedct.org/resource/agency/2845>
linkedct:location	<http://data.linkedct.org/resource/location/80179>
linkedct:nct_id	NCT00512187
linkedct:number_of_arms	2 (xsd:int)
linkedct:number_of_groups	0 (xsd:int)
linkedct:official_title	Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
linkedct:org_study_id	GISONDI 1
linkedct:overall_official	<http://data.linkedct.org/resource/overall_official/20031>
linkedct:overall_status	Completed
linkedct:oversight	<http://data.linkedct.org/resource/oversight/1550>
foaf:page	<http://clinicaltrials.gov/show/NCT00512187>
linkedct:phase	Phase 4
linkedct:primary_outcomes	<http://data.linkedct.org/resource/primary_outcomes/77144>
linkedct:secondary_id	no grants received at all
linkedct:secondary_outcomes	<http://data.linkedct.org/resource/secondary_outcomes/99005>
linkedct:source	Universita di Verona
linkedct:start_date	November 2005
linkedct:study_design	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type	Interventional
linkedct:summary	The study hypothesis is to investigate whether a moderate weight loss (i.e. a weight reduction of at least 5%) could improve the response rate to a suboptimal dose of cyclosporine in patients with severe psoriasis.
rdf:type	linkedct:trials
linkedct:verification_date	August 2007

LinkedCT.org