A multicentre, open label Phase IIIb/IV study of subcutaneously administered efalizumab in the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA. - efalizumab physician experience study

Conditions: Adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporin, methotrexate and PUVA
MedDRA version: 7.0Level: PTClassification code 10037153

Registration Number: EUCTR2004-001236-23-FI

Lead Sponsor: Serono International S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

1. Moderate to severe plaque psoriasis patients who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA.
2. At least 18 years old.
3. For women of childbearing potential and for men whose partner can become pregnant, 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 and up to 3 months after the last dose of efalizumab.
4. Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that the consent may be withdrawn by the patient at any time without prejudice to future medical care.
5. Discontinuation of any systemic psoriasis treatment. No washout period is required for these systemic psoriasis agents prior to starting study and receiving first dose of study drug (efalizumab).
6. Discontinuation of all biologic agents (other than efalizumab) 3 months prior to receiving first dose of study drug (efalizumab).
7. Discontinuation of any investigational drug or treatment 3 months prior to study day 0 as per washout requirements from previous protocol.
8. No primary vaccinations (eg, tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.
9. The patient must be willing and able to comply with the protocol requirements for the duration of the study.
10. Patients previously treated with efalizumab will be permitted to enter this study, unless they withdrew from this previous therapy due to a lack of efficacy or an adverse event that was deemed related to efalizumab, and that they meet all inclusion criteria and none of the exclusion criteria within the 14 days prior to study day 0.

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. Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis.
2. Patients who have previously been on efalizumab treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination , or infection) then the patient can be included in this study.
3. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies.
4. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection.
5. History of opportunistic infections (eg, systemic fungal infections, parasites).
6. Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
7. Pregnancy or breast feeding.
8. WBC count <4.0x109/L or >14.0x109/L.
9. Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count <100x109cells/L.
10. Seropositivity for hepatitis B or C virus. Patients will undergo testing at screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
11. History of active tuberculosis (TB) or currently undergoing treatment for TB within one year prior to study day 0. Chest X-ray (within 3 months prior to SD0) is required for high-risk patients (Protocol, appendix J). Patients with a positive chest X-ray will be excluded.
12. Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
13. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year.
14. Any medical condition that, in the judgment of the investigator, would jeopardize the patient’s safety following exposure to study drug (for example, liver cirrhosis).