A Phase IV, prospective, open label multicentre study of Raptiva 1mg/kg/week by subcutaneous injection in adults with moderate to severe chronic plaque psoriasis who have failed previous biologic therapy with etanercept. - Open label investigation of Raptiva efficacy in subjects who have failed on Enbrel.

• Conditions: Adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to biological therapy with Enbrel; MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2008-002354-38-GB
• Lead Sponsor: Merck Serono Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

i.At least 18 years of age.
ii.Have plaque psoriasis with a PASI score of at least 10 at time of initiation of etanercept treatment
iii.Have failed to respond to, or are in tolerant to, etanercept therapy as determined by their treating physician
iv.Agree to participate in the study, and disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study
v.Have given written consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care
vi.For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study
vii.Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol
.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
•Hypersensitivity to Raptiva or to any of the excipiants
•Subjects with history of malignancies, including lymphoproliferative disease.
•Subjects with active or latent tuberculosis within one year prior to screening (to be determined by assessement according to national and / or local recommendations), or other severe infections.
•Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis
•Subjects with immunodeficiencies
2. Simultaneous participation in another clinical trial
3. Subjects experiencing a psoriasis exacerbation during screening period
4. Subjects with significant psoriatic arthritis (DAS28>5.1)
5. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (eg. Vaccination) then the subject can be included in this study
6. History of hepatitis B, C or huma immunodeficiency virus (HIV)
7. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia
8. Hepatic enzyme levels >=3 times the upper limit of normal or serum creatinine level >= 2 times the upper limit of the normal
9. Pregnant or breast feeding
10. Any medical condition (prior or existing) that, in the judgement of the investigator or sponsor, could jepardize the subject’s safety following exposure to study drug
11. Subjects with body weight of >200kg
12. Vaccination with a live or live-attenuated vaccine within 14 days prior to the first dose of investigational medicinal drug

Note: Raptiva should be used with caution in subjects with renal or hepatic impairment
.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Raptiva in patients that have not responded to, or are in tolerant to previous course of etanercept 25mg twice weekly therapy;Secondary Objective: Assess the safety of Raptiva treatment following failed etanercept treatment.;Primary end point(s): Efficacy of Raptiva after 12 weeks therapy, measured as the proportion of subjects that achieve PASI 50 plus a 5-point reduction in DLQI at week 12.