Trial Review

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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
Date last updated
15/10/2024

Titles & IDs
Public title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Scientific title
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Secondary ID [1] 0 0
ICM 20-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of delayed adverse events
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Knee pain
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Knee function
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Joint space width
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Incidence of total knee replacement
Timepoint [5] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
* Previous receipt of ICM-203 or matching placebo
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ICM Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an observational study of the long term safety and efficacy of ICM-203.
Trial website
https://clinicaltrials.gov/study/NCT05752032
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alison Heald, MD
Address 0 0
ICM Co. Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05752032