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

Amgen Inc0 sites220 target enrollmentAugust 18, 2010

ConditionsRheumatoid arthritis MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid arthritis
Sponsor: Amgen Inc
Enrollment: 220
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 18, 2010

End Date

TBD

Last Updated

13 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 20090061 and completed the week 16 evaluation.
•For subjects with \= 3 months between the week 16 visit of 20090061 and
•the planned first IP dose in 20090402: 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 20090061 and the planned first IP dose in 20090402, a negative urine pregnancy test at baseline prior to the first IP dose in 20090402 (except those at least 3 years post menopausal or surgically sterile).
•For female subjects with \> 4 weeks between the week 16 visit of 20090061 and the planned first IP dose in 20090402, 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 IP in 20090402 (except those at least 3 years post menopausal or surgically sterile).
•For subjects with \= 3 months between the week 16 visit of 20090061 and the planned first IP dose in 20090402:
•If the subject entered 20090061 with a negative purified protein derivative (PPD) test: Subject must have a negative PPD test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48\-72 hours after test is placed.
•If the subject entered 20090061 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 SAE reported during 20090061 that was considered to be related to IP.
•Subject experienced an adverse event in 20090061 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 is resolved in the opinion of the investigator.
•For subjects with \> 4 weeks between the week 16 visit of 20090061 and the planned first IP dose in 20090402, subject has laboratory abnormalities at screening, including:
•Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); \>1\.5x upper limit of normal)
•Serum total bilirubin \=1\.5 mg/dL
•Hemoglobin \< 11 g/dL
•Platelet count \< 125,000 /mm3
•White blood cell count \< 3,000 cells/mm3
•Absolute neutrophil count \< 2000/mm3