ChangE From Any Systemic psoriasiS therapY to Raptiva

A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697593

Acronym

EASY

Enrollment

Registered

2008-06-16

Start date

2008-01-31

Completion date

2009-04-30

Last updated

2014-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

Efalizumab, Chronic Plaque Psoriasis, Transition from systemic therapies on to Efalizumab

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.

Interventions

DRUGEfalizumab - anti CD11a recombinant human monoclonal antibody (mAb)

Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Are at least 18 years old. 2. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment. 3. 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. 4. 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. 5. Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care. 6. 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. 7. 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

1. 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. 2. Simultaneous participation in another clinical trial. 3. Subjects experiencing a psoriasis exacerbation during screening period. 4. 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. 5. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). 6. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia. 7. Hepatic enzyme levels =/\>3 times the upper limit of normal or serum creatinine level =/\>2 times the upper limit of normal. 8. Pregnant or breast-feeding. 9. 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.

Design outcomes

Primary

Measure	Time frame	Description
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
Hematology - Hematocrit	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 - Neutrophils	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
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
Hematology - Platelet Count	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 - 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 - Total Bilirubin	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 - Alkaline Phosphatase	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
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
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 - 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 - 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 - 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 - 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

Secondary

Measure	Time frame	Description
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).

Countries

Canada

Participant flow

Recruitment details

Date of first subject first visit: 22 January 2008 Date of last subject last visit: 21 April 2009 Subjects were enrolled at 13 study centers in 2 countries, including 10 study centers in Canada and 3 study centers in the Netherlands.

Pre-assignment details

Subjects were to be screened for study eligibility within 14 days before Day 1

Participants by arm

Arm	Count
Efalizumab Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection	70
Total	70

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	3
Overall Study	Lack of Efficacy	3
Overall Study	Protocol Violation	1
Overall Study	Suspension of the study by sponsor	12

Baseline characteristics

Characteristic	Efalizumab
Age, Continuous	46.9 years STANDARD_DEVIATION 14.7
Age, Customized 18 - 40 years	26 participants
Age, Customized 41 to 64 years	36 participants
Age, Customized >64 years	8 participants
Biochemistry - Alanine Transaminase (ALT)	27.8 IU/L STANDARD_DEVIATION 12.2
Biochemistry - Alkaline Phosphatase	76.6 IU/L STANDARD_DEVIATION 19
Biochemistry - Aspartate Transaminase (AST)	23.0 IU/L STANDARD_DEVIATION 7.8
Biochemistry - C-Reactive Protein (CRP) Participants with <3 mg/L	36 participants
Biochemistry - C-Reactive Protein (CRP) Participants with 3 mg/L-6mg/L	19 participants
Biochemistry - C-Reactive Protein (CRP) Participants with >6 mg/L	15 participants
Biochemistry - Creatinine	82.9 μmol/L STANDARD_DEVIATION 18.9
Biochemistry - Glutamyl Transferase	25.9 IU/L STANDARD_DEVIATION 15.3
Biochemistry - Potassium	4.19 mmol/L STANDARD_DEVIATION 0.36
Biochemistry - Total Bilirubin	8.0 μmol/L STANDARD_DEVIATION 4.7
Biochemistry - Urea	5.677 mmol/L STANDARD_DEVIATION 1.633
Biochemistry - Values: Sodium	139.5 mmol/L STANDARD_DEVIATION 1.9
Hematology - Basophils	0.032 x10^9/L STANDARD_DEVIATION 0.033
Hematology - Eosinophils	0.177 x10^9/L STANDARD_DEVIATION 0.135
Hematology - Hematocrit	0.430 packed cell volume STANDARD_DEVIATION 0.04
Hematology - Hemoglobin	145.0 g/L STANDARD_DEVIATION 13.7
Hematology - Lymphocytes	1.911 x10^9/L STANDARD_DEVIATION 0.67
Hematology - Monocytes	0.462 x10^9/L STANDARD_DEVIATION 0.188
Hematology - Neutrophils	4.533 x10^9/L STANDARD_DEVIATION 1.582
Hematology - Platelet Count	256.0 x10^9/L STANDARD_DEVIATION 54.7
Hematology - Red Blood Cell Count	4.69 x10^12/L STANDARD_DEVIATION 0.52
Hematology - White Blood Cell Count	7.11 x10^9/L STANDARD_DEVIATION 1.95
Region of Enrollment Canada	60 participants
Region of Enrollment Netherlands	10 participants
Sex: Female, Male Female	25 Participants
Sex: Female, Male Male	45 Participants
static Physician's Global Assessment (sPGA) Clear	0 participants
static Physician's Global Assessment (sPGA) Mild	6 participants
static Physician's Global Assessment (sPGA) Minimal	4 participants
static Physician's Global Assessment (sPGA) Moderate	38 participants
static Physician's Global Assessment (sPGA) Severe	21 participants
static Physician's Global Assessment (sPGA) Very Severe	1 participants
Urinalysis - Blood Negative	66 participants
Urinalysis - Blood Present	4 participants
Urinalysis - Glucose Negative	66 participants
Urinalysis - Glucose Present	4 participants
Urinalysis - Ketones Negative	67 participants
Urinalysis - Ketones Present	3 participants
Urinalysis - Leukocytes Esterase Negative	60 participants
Urinalysis - Leukocytes Esterase Present	10 participants
Urinalysis - pH	5.84 pH units STANDARD_DEVIATION 0.49
Urinalysis - Values - Nitrite Negative	69 participants
Urinalysis - Values - Nitrite Positive	1 participants
Urinalysis - Values - Protein Negative	59 participants
Urinalysis - Values - Protein Present	11 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	50 / 70
serious Total, serious adverse events	0 / 70

Outcome results

Primary

Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis

Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above