A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Psoriasis.

Amgen Inc0 sites160 target enrollmentMay 20, 2010

ConditionsModerate to severe plaque psoriasis MedDRA version: 17.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Moderate to severe plaque psoriasis
Sponsor: Amgen Inc
Enrollment: 160
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 20, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Amgen Inc

Eligibility Criteria

Inclusion Criteria

•Subject has provided informed consent.
•Subject was randomized into Study 20090062 and completed the week 16 evaluation.
•For subjects with \= 3 months between the week 16 visit of 20090062 and
•the planned first IP dose in 20090403: Negative test for hepatitis B virus (HBV)
•surface antigen, hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) in subjects if clinically indicated (eg, known recent exposure) in the opinion of the investigator.
•For female subjects with \= 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, a negative urine pregnancy test at baseline prior to the first dose of study drug in 20090403 (except those at least 3 years post menopausal or surgically sterile).
•For female subjects with \> 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, a negative serum pregnancy test within 28 days prior to initiating IP and a negative urine pregnancy test at baseline prior to the first dose of study drug in 20090403 (except those at least 3 years post menopausal or surgically sterile).
•For subjects with \= 3 months between the week 16 visit of Study 20090062 and the first planned IP dose of 20090403:
•If the subject entered Study 20090062 with a negative purified protein derivative (PPD) test: Subject must have a negative PPD test within 30 days prior to the first planned IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48 to 72 hours after test is placed.
•If the subject entered Study 20090062 with a positive PPD and has had a subsequent exposure to tuberculosis: Subject must have a negative Quantiferon test within 30 days prior to the first IP dose.

Exclusion Criteria

•Subject had any Serious Adverse Event reported during Study 20090062 that was considered possibly related to IP.
•Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.
•Subject is currently experiencing an infection of CTCAE grade 2 (if requiring oral antibiotics) or higher. Subject is ineligible until the infection resolves.
•For subjects with \> 4 weeks between the week 16 visit of Study 20090062 and the first planned IP dose in 20090403, subject has laboratory abnormalities at screening, including:
•· Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); \> 1\.5x the upper limit of normal.
•· Serum total bilirubin \= 1\.5 mg/dL.
•· Hemoglobin \< 11 g/dL.
•· Platelet count \< 125,000 cells/mm3\.
•· White blood cell count \< 3,000 cells/mm3\.
•· Absolute neutrophil count \< 2,000 cells/mm3\.