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TERMINATEDPHASE2

Safety and Efficacy of AMG 827 in Subjects With RA

A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis

NCT01059448•Amgen

View on ClinicalTrials.gov

Summary

This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989). All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent.
•Subject was randomized into study 20090061 and completed the week 16 evaluation.
•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.
•Subject must test negative for Tuberculosis.

Exclusion Criteria

•Subject had any SAE reported during 20090061 that was considered to be related to IP.
•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
•Estimated creatinine clearance \< 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites)
+26 more criteria

Locations (44)

Research Site

Scottsdale, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

La Jolla, California, United States

Research Site

Victorville, California, United States

Research Site

Sarasota, Florida, United States

Research Site

Rock Island, Illinois, United States

Research Site

Springfield, Illinois, United States

Research Site

Lexington, Kentucky, United States

Research Site

Grand Rapids, Michigan, United States

Research Site

Lansing, Michigan, United States

Key Dates

Start Date

June 3, 2010

Primary Completion Date

April 5, 2011

Completion Date

April 5, 2011

Last Updated

February 28, 2022

Enrollment

211

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

AMG 827

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of AMG 827 in Subjects With RA

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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