Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
Subject has a significant concurrent medical conditions, including:
Type 1 diabetes
Poorly controlled type 2 diabetes (Hemoglobin A1c \> 8.5)
Symptomatic heart failure (New York Heart Association class II, III, or IV)
Myocardial infarction within the last year
Current or history of unstable angina pectoris within the last year
Uncontrolled hypertension as defined by resting blood pressure \> 150/90 mmHg prior to first IP dose (confirmed by a repeat assessment)
Severe chronic pulmonary disease (eg, requiring oxygen therapy)
Major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus), with the exception of secondary Sjögren's syndrome
Multiple sclerosis or any other demyelinating disease
Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)
Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject
Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject's last study visit including the follow-up period.
Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study and at least 40 days after the last dose (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier methods used by the man.
Male subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study, plus an additional 16 weeks after the last dose (except for men who are surgically sterile or whose female partners are at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control include but are not limited to a condom in combination with hormonal birth control or barrier methods used by the woman.
Male subject (including vasectomised males) with a pregnant female partner is not willing to use effective methods to ensure that an unborn child is not exposed to AMG 827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG 827 via semen include condoms or abstinence.
Subject has used any of the following within 14 days prior to IP initiation
Non-biologic disease-modifying anti-rheumatic drugs (DMARD) other than as allowed in 20090061
Intra-articular, intramuscular, or intravenous corticosteroids, including adrenocorticotropic hormone
Subject has used any of the following within 3 months prior to IP initiation
Leflunomide
Live vaccines
Commercially available or experimental biologic DMARD except for AMG 827
Subject has received gold therapy within 6 months prior to IP initiation.
Subject received another investigational agent (other than AMG 827) or participated in an investigational device study subsequent to 20090061.
Other investigational procedures are excluded.
Clareo Health | Safety and Efficacy of AMG 827 in Subjects With RA
