Raptiva in Moderate to Severe Psoriasis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Moderate to Severe Psoriasis

Intervention / Treatment

Drug: Raptiva

Study Type

Interventional

Enrollment (Actual)

793

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Geneva, Switzerland, 1202
    - Serono International SA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Signed informed consent
Plaque psoriasis covering ³10% of total BSA (see Appendix A)
Diagnosis of psoriasis for at least 6 months
A minimum PASI score of 12.0 at screening (see Appendix A)
Patients who are either not controlled by, intolerant to or contraindicated to at least 2 currently available systemic therapies (e.g., photochemotherapy (PUVA), cyclosporin, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP) (defined as "high need" patients)
Body weight <= £120 kg
18 to 75 years old
For women of childbearing potential, 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
Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
Willingness to enter Study

Exclusion Criteria:

Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies or fusion proteins that contain an Ig Fc region
Clinically significant psoriasis flare during screening or at the time of enrollment
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
WBC count <4000/mL or >14,000/mL
Seropositivity for hepatitis B or C virus Patients will undergo testing during screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
Hepatic enzymes ³3 times the upper limit of normal
History of active tuberculosis (TB) or currently undergoing treatment for TB PPD testing or chest X-ray is required for high risk patients (see Appendix I). Patients with a positive PPD (not due to BCG vaccination) or 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.
Previous treatment with Raptiva (anti-CD11a)
Diagnosis of hepatic cirrhosis, regardless of cause or severity
Serum creatinine ³2 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

Note: Restrictions and/or directions apply to the following treatments during specified time periods prior to initial study drug administration and during the study:

Systemic therapy for psoriasis (within 28 days prior to Study Day 0)
Systemic immunosuppressive drugs for other indications (within 28 days prior to Study Day 0)
Topical therapies for psoriasis (within 14 days prior to Study Day 0)
Live or killed virus or bacteria vaccines (within 14 days prior to Study Day 0)
Other vaccines or allergy desensitisation (it is recommended that these are scheduled at least 14 days prior to Day 0 or ³3 months after the last injection of study drug)
Other experimental drugs or treatments (within 28 days or five half lives, whichever is longer, prior to Day 0) b Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant from Day -28 throughout the study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

Study Director: Patrick Natta, M.D., Sponsor GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

CLEAR trial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

November 18, 2005

First Submitted That Met QC Criteria