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 cyclosporine, methotrexate and PUVA MedDRA version: 7.0 Level: PT Classification code 10037153
Conditions
Interventions
Product Name: RAPTIVA
Product Code: Not applicable
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: efalizumab
Current Sponsor code: Not applicable
Concentration
Sponsors
Serono International S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 cyclosporine, methotrexate and PUVA OR Subjects who have completed the CLEAR study IMP 24011 and are eligible according to the above criterion and who wish to continue or restart efalizumab therapy. 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5. Discontinuation of any systemic psoriasis treatment as described in section 6.2.2 of the protocol. 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 or 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. 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. 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 14.0x109/L. 9. Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count <100,000 cells/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish control of moderate to severe chronic plaque psoriasis with efalizumab in patients who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate and PUVA;Secondary Objective: To evaluate the management of patients discontinuing efalizumab.;Primary end point(s): Proportion of patients achieving a PGA of change (Physician Global Assessment - 7 points score), rated Good, Excellent or Cleared at week 12. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Hungary, Ireland, Italy, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed