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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05752032
Registration number
NCT05752032
Ethics application status
Date submitted
21/02/2023
Date registered
2/03/2023
Titles & IDs
Public title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
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Scientific title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
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Secondary ID [1]
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ICM 20-1002
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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:
Osteoarthritis, Knee
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - ICM-203
Treatment: Drugs - Placebo
ICM-203 - Participants who previously received ICM-203 in ICM-203 clinical studies
Placebo - Participants who previously received placebo in ICM-203 clinical studies
Treatment: Other: ICM-203
Long term follow-up
Treatment: Drugs: Placebo
Long term follow-up
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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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 of delayed adverse events
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Assessment method [1]
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
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Knee pain
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Assessment method [1]
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Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable)
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Knee function
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Assessment method [2]
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Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems)
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
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Assessment method [3]
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Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Joint space width
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Assessment method [4]
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Evaluation of change from baseline in joint space width in mm as measured on knee radiograph
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Incidence of total knee replacement
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Assessment method [5]
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Timepoint [5]
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Up to 5 years
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Eligibility
Key inclusion criteria
* Previous receipt of ICM-203 or matching placebo
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Minimum age
50
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
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
16/03/2023
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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
1/12/2028
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Barwon Health - Geelong
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3220 - Geelong
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ICM Co. Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an observational study of the long term safety and efficacy of ICM-203.
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Trial website
https://clinicaltrials.gov/study/NCT05752032
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alison Heald, MD
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Address
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ICM Co. Ltd.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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)?
No
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No/undecided IPD sharing reason/comment
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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/NCT05752032