Adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to biological therapy with Enbrel MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Raptiva 100mg/ml powder and solvent for injection
Product Name: Raptiva
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Concentration uni
Sponsors
Merck Serono Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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requirements for the duration of the study v. Have given written consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care vi.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
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed