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CLEAR Study: Clinical Experience Acquired With Raptiva Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

CLEAR Study: Clinical Experience Acquired With Raptiva Study

NCT00256139•Merck KGaA, Darmstadt, Germany

Summary

A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered Raptiva in the treatment of patients with moderate to severe psoriasis

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+15 more criteria

Locations (1)

Serono International SA

Geneva, Switzerland

Key Dates

Start Date

March 1, 2003

Primary Completion Date

October 1, 2004

Completion Date

October 1, 2004

Last Updated

January 16, 2017

Enrollment

793

ACTUAL participants

Conditions

Moderate to Severe Psoriasis

Interventions

Raptiva

DRUG