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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01470599
Registration number
NCT01470599
Ethics application status
Date submitted
27/10/2011
Date registered
11/11/2011
Date last updated
16/10/2017
Titles & IDs
Public title
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
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Scientific title
A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
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Secondary ID [1]
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2011-003622-27
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Secondary ID [2]
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A3921086
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Experimental: 5mg BID -
Experimental: 10mg BID -
Treatment: Drugs: CP-690,550
ORAL TABLET, TWICE DAILY
Treatment: Drugs: CP-690,550
ORAL TABLETS, TWICE DAILY
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adjudicated Potential Cardiovascular Events
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Assessment method [1]
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Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.
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Timepoint [1]
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From baseline to Week 52
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Primary outcome [2]
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Adjudicated Malignancy Events
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Assessment method [2]
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Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.
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Timepoint [2]
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From baseline to Week 52
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Primary outcome [3]
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Adjudicated Hepatic Injury Events
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Assessment method [3]
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Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST =5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST =3xULN, bilirubin =2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery & liver failure (all yes, no or undetermined).
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Timepoint [3]
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From baseline to Week 52
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Primary outcome [4]
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Adjudicated Opportunistic Infection Events
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Assessment method [4]
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Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).
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Timepoint [4]
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From baseline to Week 52
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Primary outcome [5]
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Adjudicated Gastrointestinal (GI) Perforation Events
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Assessment method [5]
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Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.
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Timepoint [5]
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From baseline to Week 52
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Primary outcome [6]
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Adjudicated Interstitial Lung Disease (ILD) Events
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Assessment method [6]
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Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).
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Timepoint [6]
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From baseline to Week 52
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Secondary outcome [1]
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Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48
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Assessment method [1]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study
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Assessment method [2]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
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Timepoint [2]
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Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [3]
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Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study
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Assessment method [3]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.
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Timepoint [3]
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Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [4]
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Time to Relapse Among Participants in Clinical Remission at Baseline
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Assessment method [4]
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Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves.
n = number of participants remaining at risk.
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Timepoint [4]
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From baseline to Week 52
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Secondary outcome [5]
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Observed CDAI Score by Week
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Assessment method [5]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.
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Timepoint [5]
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Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [6]
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Change From Baseline Observed CDAI Score by Week
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Assessment method [6]
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CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.
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Timepoint [6]
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Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [7]
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Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline
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Assessment method [7]
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Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
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Timepoint [7]
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Week 48
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Secondary outcome [8]
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Corticosteroid Use Over Time
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Assessment method [8]
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Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.
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Timepoint [8]
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Weeks 8, 16, 24, 36 and 48
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Secondary outcome [9]
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Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit
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Assessment method [9]
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There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.
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Timepoint [9]
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From baseline to Week 48
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Secondary outcome [10]
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Observed Change From Baseline in Fecal Calprotectin by Week
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Assessment method [10]
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Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.
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Timepoint [10]
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Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [11]
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Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week
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Assessment method [11]
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The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.
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Timepoint [11]
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Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up
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Secondary outcome [12]
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Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit
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Assessment method [12]
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The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.
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Timepoint [12]
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Baseline and Week 48/early termination (ET)
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Secondary outcome [13]
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Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit
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Assessment method [13]
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The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.
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Timepoint [13]
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Baseline and Week 48/ET
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Secondary outcome [14]
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Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (=) 170 at Week 48/ET Visit
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Assessment method [14]
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The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score =170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.
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Timepoint [14]
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Week 48/ET
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Secondary outcome [15]
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Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category
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Assessment method [15]
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The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.
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Timepoint [15]
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Week 48/ET visit
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Secondary outcome [16]
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Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit
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Assessment method [16]
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The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
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Timepoint [16]
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Baseline and Week 48/ET visit
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Secondary outcome [17]
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Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit
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Assessment method [17]
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The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.
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Timepoint [17]
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Baseline and Week 48/ET visit
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Secondary outcome [18]
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EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit
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Assessment method [18]
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EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data.
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Timepoint [18]
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Baseline and Week 48/ET visit
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Secondary outcome [19]
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Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit
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Assessment method [19]
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EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state.
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Timepoint [19]
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Baseline and Week 48/ET visit
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Secondary outcome [20]
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EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit
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Assessment method [20]
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EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.
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Timepoint [20]
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Baseline and Week 48/ET visit
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Secondary outcome [21]
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Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit
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Assessment method [21]
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EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
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Timepoint [21]
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Baseline and Week 48/ET visit
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Secondary outcome [22]
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Percentage of Participants Hospitalized Due to Crohn's Disease
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Assessment method [22]
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The number of participants hospitalized due to Crohn's disease were recorded at every study visit.
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Timepoint [22]
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From baseline to Week 52/follow-up
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Secondary outcome [23]
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Length of Hospitalizations Due to Crohn's Disease
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Assessment method [23]
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The length of hospitalizations due to Crohn's disease were recorded at every study visit.
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Timepoint [23]
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From baseline to Week 52/follow-up
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Eligibility
Key inclusion criteria
- Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects
who withdraw early due to A3921084 study treatment failure (see Appendix 5).
- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.
- Sexually active females of childbearing potential are required to use adequate
contraceptive methods during the study period and until completion of the follow-up
procedures. No specific contraceptive measures are required in male subjects during
study participation.
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Minimum age
18
Years
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Maximum age
76
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who have been discontinued due to protocol violation(s) (as determined by the
Sponsor) in the A3921084 study.
- Subjects who were discontinued from the A3921084 study due to an adverse event.
- Subjects likely to require any non-elective surgery or surgery requiring overnight
stay (with the exception of minor same day outpatient procedures that will not
interfere with study drug dosing).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2016
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
Nepean Public Hospital - Kingswood
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Recruitment hospital [2]
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0
Monash Medical Centre - Clayton
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Recruitment hospital [3]
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0
Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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0
2747 - Kingswood
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Recruitment postcode(s) [2]
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0
3168 - Clayton
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Recruitment postcode(s) [3]
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0
3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Michigan
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Ohio
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Utah
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Virginia
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Wisconsin
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Country [12]
0
0
Austria
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State/province [12]
0
0
Wien
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Country [13]
0
0
Bulgaria
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State/province [13]
0
0
Sofia
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Country [14]
0
0
Canada
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State/province [14]
0
0
British Columbia
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Country [15]
0
0
Canada
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State/province [15]
0
0
Ontario
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Country [16]
0
0
Canada
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State/province [16]
0
0
Quebec
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Country [17]
0
0
Czechia
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State/province [17]
0
0
Hradec Kralove
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Country [18]
0
0
Czechia
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State/province [18]
0
0
Hradec Králové
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Country [19]
0
0
France
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State/province [19]
0
0
Lille Cedex
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Country [20]
0
0
France
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State/province [20]
0
0
Pessac Cedex
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Country [21]
0
0
Germany
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Berlin
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Germany
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Kiel
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Germany
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Ulm
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Greece
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Kolonaki Athens
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Hungary
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Budapest
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Hungary
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Gyongyos
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Hungary
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Szekszard
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Miyagi
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Japan
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Chiba
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Japan
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Osaka
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Korea, Republic of
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Seoul
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Korea, Republic of
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Soeul
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Netherlands
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Amsterdam
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South Africa
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Durban
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Spain
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Barcelona
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Spain
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Madrid
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Ukraine
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Odesa
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Ukraine
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Vinnitsa
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Funding & Sponsors
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Commercial sector/Industry
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Pfizer
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Summary
Brief summary
The study hypothesis is to establish the safety and tolerability of long-term open-label (OL)
CP-690,550 therapy in subjects with Crohn's disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01470599
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01470599
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