Safety and Efficacy of AMG 827 in Subjects With RA
- Conditions
- MedDRA version: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2009-016119-38-GB
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
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.
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
• Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites)
• Hemoglobin A1c > 8.5 (for type 2 diabetics only)
• Any other laboratory abnormality, which, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results
For subjects with = 3 months between the week 16 visit of 20090061 and the planned first IP dose in 20090402, subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics within 8 weeks before screening.
For subjects with = 3 months between the week 16 visit of 20090061 and the planned first IP dose in 20090402, subject has recurrent or chronic infections, defined as = 3 infections requiring anti-microbials over the past 12 months prior to screening.
Subject has a significant concurrent medical conditions, including:
• Type 1 diabetes
• Poorly controlled type 2 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 t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method