ChangE From Any Systemic psoriasiS therapY to Raptiva

Chronic Plaque Psoriasis Clinical Trial

— EASY  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00697593
• Other study ID #: 27809
• Status: Terminated
• Phase: Phase 4
• First received: June 11, 2008
• Last updated: January 20, 2014
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care.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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Efalizumab - 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.

Locations

Country	Name	City	State
Canada	Probity Medical Research	City Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematology - Hematocrit	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Hemoglobin	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Red Blood Cell Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - White Blood Cell Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Neutrophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Eosinophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Basophils	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Monocytes	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Lymphocytes	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Hematology - Platelet Count	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Sodium	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Potassium	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Creatinine	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Total Bilirubin	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Aspartate Transaminase (AST)	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Alanine Transaminase (ALT)	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Alkaline Phosphatase	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Glutamyl Transferase	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - Urea	Blood samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Biochemistry - C-Reactive Protein (CRP)	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	Week 12 / Early Termination	Yes
Primary	Urinalysis - pH	Urine samples were taken for clinical laboratory testing	Week 12 / Early Termination	Yes
Primary	Urinalysis - Protein	Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine	Week 12 / Early Termination	Yes
Primary	Urinalysis - Ketones	Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine	Week 12 / Early Termination	Yes
Primary	Urinalysis - Glucose	Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine	Week 12 / Early Termination	Yes
Primary	Urinalysis - Blood	Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine	Week 12 / Early Termination	Yes
Primary	Urinalysis - Nitrite	Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine	Week 12 / Early Termination	Yes
Primary	Urinalysis - Leukocytes Esterase	Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine	Week 12 / Early Termination	Yes
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	Week 12 / Early Termination	Yes
Secondary	Static Physician's Global Assessment (sPGA)	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).	12 Weeks/Early Termination	No