Safety Study in Subjects With Crohn's Disease
This study has been terminated.
(Per recommendation from DRT)
Information provided by (Responsible Party):
First received: September 9, 2010
Last updated: December 14, 2015
Last verified: December 2015
This study is an open label extension of study 20090072 with subjects with Crohn's disease. Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a half years. The study will be evaluated for safety and efficacy of AMG 827.
Drug: AMG 827
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease
Primary Outcome Measures:
- To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and Crohn's Disease Activity Index (CDAI). To evaluate the maintenance of effect as measured by the HBI and CDAI [ Time Frame: 2 1/2 years ] [ Designated as safety issue: No ]
- To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn's disease. [ Time Frame: 2 1/2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine if subjects develop anti-AMG 827 antibodies; to evaluate the change of EQ-5D from baseline at all timepoints, the effect of treatment on inflammatory markers (C-reactive protein [CRP]) at post-base, and the pharmacokinetics of AMG 827. [ Time Frame: 2 1/2 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
Experimental: 350 mg
Drug: AMG 827
350 mg AMG 827 administered intraveneously at baseline, week 4, and every 4 weeks thereafter.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject was randomized into study 20090072 and completed the week 12 evaluation.
- 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.
- Subject or subject's legally acceptable representative has provided informed consent.
- Subject meets regional recommendations for immunizations, eg, United States Centers for Disease Control and Prevention recommendations for subjects enrolled in the United States.
- 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).
- For female subjects with ≤ 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile).
- For female subjects with > 4 weeks between the week 12 visit of 20090072 and the planned first dose of AMG 827 in 20100008: Subject has a negative serum pregnancy test within 28 days before initiating AMG 827 and a negative urine pregnancy test at baseline prior to the first dose of AMG 827 in the open-label extension (except those at least 2 years post menopausal or surgically sterile).
- 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) please assess the following:
- 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.
- Subject had any serious adverse event reported during study 20090072 and considered to be related to investigational product.
- Subject experienced an adverse event or laboratory abnormality in study 20090072 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results.
- Subject has known sensitivity to any of the products to be administered during dosing.
Other medical conditions
- 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.
- Subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics, within 8 weeks before the first dose of AMG 827 in 20100008.
- 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.
- 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).
- Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject
- Laboratory abnormalities
- 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)
- Any other laboratory abnormality, which, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject, prevent the subject from completing the study, or interfere with the interpretation of the study results
- Washouts and non-permitted drugs
- Subject has used Tysabri (natalizumab) subsequent to study 20090072.
- Subject received an anti-tumor necrosis factor agent within 8 weeks prior to the first dose of AMG 827 in 20100008.
- Subject received other commercially available biologic agent (eg, ustekinumab) within 12 weeks prior to the first dose of AMG 827 in 20100008.
- Subject received an investigational agent (other than AMG 827), investigational procedure, or participated in an investigational device study subsequent to study 20090072.
- Subject received live vaccines within 12 weeks prior to the first dose of AMG 827 in 20100008.
- Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, or tacrolimus within 4 weeks prior to the first dose of AMG 827 in 20100008.
- General or other
- Female subject is not willing to use highly effective contraception during treatment with AMG 827 (except if at least 2 years postmenopausal or surgically sterile).
- Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
- Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01199302
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 9, 2010
||December 14, 2015
||Australia: Therapeutic Goods Administration
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Keywords provided by Amgen:
Inflammatory Bowel Disease
Irritable Bowel Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 24, 2016
Digestive System Diseases
Inflammatory Bowel Diseases