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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05269004
Registration number
NCT05269004
Ethics application status
Date submitted
11/02/2022
Date registered
7/03/2022
Titles & IDs
Public title
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
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Scientific title
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
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Secondary ID [1]
0
0
2021-005746-15
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Secondary ID [2]
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0
MN43964
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Universal Trial Number (UTN)
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Trial acronym
OLERO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ocrelizumab
Experimental: Ocrelizumab - Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
Treatment: Drugs: Ocrelizumab
Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.
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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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Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0
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Assessment method [1]
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Timepoint [1]
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Up to 44 months
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Secondary outcome [1]
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Change in Expanded Disability Status Scale (EDSS) score over time
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Assessment method [1]
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Timepoint [1]
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Week 0, 24, 48, 72, 96, 120, 168
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Secondary outcome [2]
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Change in 9-Hole Peg Test (9HPT) over time
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Assessment method [2]
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Timepoint [2]
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Week 0, 24, 48, 72, 96, 120, 168
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Secondary outcome [3]
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Change in Timed 25-Foot Walk Test (T25FWT) over time
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Assessment method [3]
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0
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Timepoint [3]
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Week 0, 24, 48, 72, 96, 120, 168
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Secondary outcome [4]
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The number of T1 lesions and number of new or enlarging T2 lesions
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Assessment method [4]
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0
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Timepoint [4]
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Week 0, 24, 48, 72, 96, 120, 168
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Secondary outcome [5]
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The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
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Assessment method [5]
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0
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Timepoint [5]
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Week 0, 24, 48, 72, 96, 120, 168
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Eligibility
Key inclusion criteria
Inclusion criteria
* Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion criteria
* Concurrent participation in any clinical trial (other than the Parent study)
* Unable or unwilling to comply with the requirements of the protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
3/05/2022
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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
31/12/2029
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Actual
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Sample size
Target
1300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment postcode(s) [1]
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2065 - St. Leonards
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment outside Australia
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Italy
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Vologda
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Russian Federation
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Kemerovo
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Russian Federation
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Kirov
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Russian Federation
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Novosibirsk
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Russian Federation
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Perm
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Russian Federation
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Samara
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Russian Federation
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Smolensk
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Serbia
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Kragujevac
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Serbia
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NIS
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Zilina
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Spain
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Barcelona
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Spain
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Girona
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Spain
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LA Coruña
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Malaga
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Sweden
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Mölnlycke
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Sweden
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Solna
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Sweden
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Stockholm
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Switzerland
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Basel
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Switzerland
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Lugano
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Tunisia
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Mannouba
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Tunisia
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Monastir
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Turkey
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Istanbul
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Turkey
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Samsun
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Turkey
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Trabzon
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Ukraine
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Chernihiv Governorate
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Ukraine
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Kharkiv Governorate
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Ukraine
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KIEV Governorate
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United Kingdom
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Exeter
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
Brief summary
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
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Trial website
https://clinicaltrials.gov/study/NCT05269004
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05269004