ChangE From Any Systemic psoriasiS therapY to Raptiva

Phase 4

Terminated

Conditions: Chronic Plaque Psoriasis

Interventions: Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

Registration Number: NCT00697593

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary: To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 70

Inclusion Criteria

Are at least 18 years old.
Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment.
Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies.
Agree to participate in the study, and to 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.
Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.
Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis.
Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol.

No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."

Exclusion Criteria

Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
- Hypersensitivity to Raptiva or to any of the excipients.
- Subjects with history of malignancies.
- History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded.
- Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
- Subjects with immunodeficiencies.
Simultaneous participation in another clinical trial.
Subjects experiencing a psoriasis exacerbation during screening period.
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 (vaccination, or infection) then the subject can be included in this study.
History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.
Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal.
Pregnant or breast-feeding.
Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Efalizumab	Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)	-

Primary Outcome Measures

Name	Time	Method
Hematology - Platelet Count	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Hemoglobin	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Red Blood Cell Count	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - White Blood Cell Count	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Eosinophils	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Sodium	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Aspartate Transaminase (AST)	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Alanine Transaminase (ALT)	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Glutamyl Transferase	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Urea	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Hematocrit	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Neutrophils	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Basophils	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Monocytes	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Hematology - Lymphocytes	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Potassium	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Creatinine	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - Alkaline Phosphatase	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Biochemistry - C-Reactive Protein (CRP)	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values \<3 mg/L, 3-6 mg/L, and \>6 mg/L
Urinalysis - pH	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing
Biochemistry - Total Bilirubin	Week 12 / Early Termination	Blood samples were taken for clinical laboratory testing
Urinalysis - Blood	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine
Urinalysis - Protein	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine
Urinalysis - Glucose	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine
Urinalysis - Ketones	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine
Urinalysis - Nitrite	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine
Urinalysis - Leukocytes Esterase	Week 12 / Early Termination	Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine
Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis	Week 12 / Early Termination	Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above

Secondary Outcome Measures

Name	Time	Method
Static Physician's Global Assessment (sPGA)	12 Weeks/Early Termination	Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).