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A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

Primary Purpose

Candidates for Systemic Therapy for Psoriasis, Psoriasis

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Efalizumab
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidates for Systemic Therapy for Psoriasis

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A) In the opinion of the investigator, candidate for systemic therapy for psoriasis could include: Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10 Patients with the following may also be deemed to require systemic therapy in the judgement of the physician: Severe psychosocial disability (in the judgement of the physician), or Nail psoriasis, or Scalp psoriasis, or Palmar plantar psoriasis etc OR B) Subjects who have completed the CLEAR study investigational medicinal product (IMP) 24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy. Body weight of 120 kg 18 to 75 years old 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 up to 3 months after the last dose of Raptiva Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other ultraviolet (UV) light sources during the study Agreement to participate in the study Signed informed consent Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (Raptiva) Discontinuation of all biologic agents (other than Raptiva) 3 months prior to receiving first dose of study drug (Raptiva) Discontinuation of Psoralen-ultraviolet light A (PUVA), Ultraviolet light B (UVB) treatment 28 days prior to commencement of receiving first dose of study drug. Discontinuation of any investigational drug or treatment 3 months prior to study Day 0 or as per washout requirements from previous protocol No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug Treatment regimens of b-blockers, Angiotensin-converting enzyme (ACE) inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to first dose of study drug Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis Active rebound of psoriasis during or following discontinuation of the previous Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due to another non drug reason (vaccination, or infection) then the patient can be included in this study. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded. Pregnancy or lactation White blood cell (WBC) count <4000 per Liter (L) or >14,000/L Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 00,000 cells/L 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. Hepatic enzymes >3 times the upper limit of normal 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 Study Day 0) is required for high-risk patients. Patients with a positive chest X-ray will be excluded. 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. Diagnosis of hepatic cirrhosis, regardless of cause or severity Serum creatinine >2 times the upper limit of normal Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year History of substance abuse within the last 5 years Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug

Sites / Locations

  • Medical Information Switzerland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Efalizumab

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2006
Last Updated
August 29, 2017
Sponsor
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00287118
Brief Title
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Official Title
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 27, 2004 (Actual)
Primary Completion Date
May 30, 2006 (Actual)
Study Completion Date
May 30, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany

4. Oversight

5. Study Description

Brief Summary
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidates for Systemic Therapy for Psoriasis, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Efalizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Efalizumab
Other Intervention Name(s)
Raptiva
Intervention Description
Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24
Description
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A) In the opinion of the investigator, candidate for systemic therapy for psoriasis could include: Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10 Patients with the following may also be deemed to require systemic therapy in the judgement of the physician: Severe psychosocial disability (in the judgement of the physician), or Nail psoriasis, or Scalp psoriasis, or Palmar plantar psoriasis etc OR B) Subjects who have completed the CLEAR study investigational medicinal product (IMP) 24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy. Body weight of 120 kg 18 to 75 years old 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 up to 3 months after the last dose of Raptiva Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other ultraviolet (UV) light sources during the study Agreement to participate in the study Signed informed consent Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (Raptiva) Discontinuation of all biologic agents (other than Raptiva) 3 months prior to receiving first dose of study drug (Raptiva) Discontinuation of Psoralen-ultraviolet light A (PUVA), Ultraviolet light B (UVB) treatment 28 days prior to commencement of receiving first dose of study drug. Discontinuation of any investigational drug or treatment 3 months prior to study Day 0 or as per washout requirements from previous protocol No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug Treatment regimens of b-blockers, Angiotensin-converting enzyme (ACE) inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to first dose of study drug Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis Active rebound of psoriasis during or following discontinuation of the previous Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due to another non drug reason (vaccination, or infection) then the patient can be included in this study. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection History of opportunistic infections (e.g., systemic fungal infections, parasites) Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded. Pregnancy or lactation White blood cell (WBC) count <4000 per Liter (L) or >14,000/L Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 00,000 cells/L 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. Hepatic enzymes >3 times the upper limit of normal 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 Study Day 0) is required for high-risk patients. Patients with a positive chest X-ray will be excluded. 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. Diagnosis of hepatic cirrhosis, regardless of cause or severity Serum creatinine >2 times the upper limit of normal Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year History of substance abuse within the last 5 years Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Medical Information Switzerland
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20098510
Citation
Stengel FM, Petri V, Campbell GA, Dorantes GL, Lopez M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D; International IMP25161 Study Group. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x.
Results Reference
result

Learn more about this trial

A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

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