A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

4.1.1 Subject was randomized into study 20090072 and completed the week 12 evaluation.
4.1.2 Subject completed the week 12 evaluation in study 20090072 no more
than 1 year prior to the planned first visit of AMG 827 in 20100008.
4.1.5 For subjects with * 3 months between the week 12 visit of 20090072 and
the planned first dose of AMG 827 in 20100008: If testing is clinically
indicated in the opinion of the investigator (eg, because of known recent
exposure), then subject has negative test for hepatitis B, hepatitis C,
and/or human immunodeficiency virus (HIV).
4.1.8 For subjects with * 3 months between the week 12 visit of 20090072 and
the planned first dose of AMG 827 in 20100008, if clinically indicated in
the opinion of the investigator (eg, because of known recent exposure):
* If the subject entered 20090072 with a negative purified protein
derivative (PPD) test: Subject must have a negative PPD test within
30 days prior to the planned first dose of AMG 827. 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 20090072 with a positive PPD: Subject must
have a negative Quantiferon test within 30 days prior to the planned
first dose of AMG 827.

Exclusion Criteria

AMG 827 specific criteria
4.2.1 Subject had any serious adverse event reported during study 20090072
and considered to be related to investigational product.
Other medical conditions
4.2.4 Subject is currently experiencing an infection of Common Terminology
Criteria for Adverse Events grade 2 (if requiring oral medication) or
higher. Subject is ineligible until the infection resolves.
4.2.5 Subject has a serious infection, defined as requiring hospitalization or
intravenous antibiotics, within 8 weeks before the first dose of AMG 827
in 20100008.
4.2.6 For subjects with * 3 months between the week 12 visit of 20090072 and
the planned first dose of AMG 827 in 20100008: Subject has recurrent or
chronic infections, defined as * 3 infections requiring anti-microbials over
the past 12 months prior to screening.
4.2.7 Subject has a significant concurrent medical condition, including
* Type 1 diabetes
* Uncontrolled type 2 diabetes
* Moderate to severe heart failure (New York Heart Association class 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 investigational product dose (confirmed
by a repeat assessment)
* Severe chronic pulmonary disease (eg, requiring oxygen therapy)
* Major chronic inflammatory disease or connective tissue disease
other than Crohn*s disease (eg, systemic lupus erythematosus,
rheumatoid arthritis, psoriasis)
* Active malignancy, including evidence of cutaneous basal or
squamous cell carcinoma or melanoma
* History of cancer (except successfully treated in situ cervical cancer
or squamous or basal cell carcinoma of the skin).
Laboratory abnormalities
4.2.8 For subjects with > 4 weeks between the week 12 visit of 20090072 and
the planned first dose of AMG 827 in 20100008, subject has laboratory
abnormalities at screening, including
* Elevated aspartate aminotransferase or alanine aminotransferase
(> 2x upper limit of normal)
* Serum direct bilirubin * 1.5x upper limit of normal
* Hemoglobin < 10 g/dL
* Hemoglobin A1c > 8.0 (for subjects with type 2 diabetes)
* Platelet count < 125,000 /mm3
* White blood cell count < 3,000 cells/mm3
* Absolute neutrophil count < 2,000/mm3
* Creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab
will calculate value and provide to sites)
Washouts and non-permitted drugs
4.2.9 Subject has used Tysabri (natalizumab) subsequent to study 20090072.
4.2.10 Subject received an anti-tumor necrosis factor agent within 8 weeks prior
to the first dose of AMG 827 in 20100008.
4.2.11 Subject received other commercially available biologic agent (eg,
ustekinumab) within 12 weeks prior to the first dose of AMG 827 in
20100008.
4.2.12 Subject received an investigational agent (other than AMG 827),
investigational procedure, or participated in an investigational device
study subsequent to study 20090072.
4.2.13 Subject received live vaccines within 12 weeks prior to the first dose of
AMG 827 in 20100008.
4.2.14 Subject received cyclosporine, mycophenolate mofetil, sirolimus
(rapamycin), thalidomide, or tacrolimus within 4 weeks prior to the first
dose of AMG 827 in 20100008.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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