CLOSED (duplicate) TRUST Study: Raptiva in Hand & Foot Psoriasis

• Research type

  Research Study

• Full title

  A Phase IV multicentre, randomised, double-blind, placebo controlled, trial to evaluate the safety and efficacy of Raptiva in the treatment of subjects with moderate to severe plaque psoriasis involving hands and/or feet, with or without pustules.

• IRAS ID

  5005

• Sponsor organisation

  Merck Serono S.A. - An affiliate of Merck KGaA

• Eudract number

  2007-004227-37

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This study will investigate howsafe and effective Raptiva is in the treatment of moderate to severe long-termplaque psoriasis specifically in subjects who also have some diseaseinvolvement in their hands and/or feet. Although currently available data showsthat Raptiva can effectively treat this disease (both overall, and specificallyin hands and feet), further data is required to substantiate the existinginformation. This trial is designed to compare Raptiva to placebo (a non-activedrug substitute). Although this is unusual in trials of drugs that are alreadylicensed, this allows the researchers to gain a more realistic measure of howeffective Raptiva is in this setting. This information is important, as handand foot psoriasis is particularly debilitating. At study start subjects willbe randomly assigned to receive either Raptiva or placebo, at a 2:1 ratio.Subjects in the Raptiva group will receive active drug for 12 weeks; subjectsin the placebo group will receive placebo for 12 weeks. After the first 12weeks, subjects in the Raptiva group who show at least a 50% improvement intheir disease, and all subjects in the placebo group, will continue on Raptivafor a further 12 weeks. Subjects responding to and tolerating Raptiva at theend of the study may be given the option to continue on this therapy. Subjectswill attend regular clinic visits for disease and general health assessments.The potential benefit for subjects will be either finding a drug for theirdisease to which they respond effectively, or finding a drug which they can tolerate(in terms of side effects) more easily. The study will recruit 168 subjects atapproximately 40 European'sites. Of these, up to 18 subjects will be recruitedat 3 UKsites. The study is being funded by the Sponsor, Merck Serono S.A.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  08/H0304/79

• Date of REC Opinion

  10 Nov 2008

• REC opinion

  Further Information Favourable Opinion