Enrolling by invitation NCT05752032
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICM-203, Placebo.
- Who it may be relevant to
- Registry conditions: Osteoarthritis, Knee. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is an observational study of the long term safety and efficacy of ICM-203.
Detailed description
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.
Interventions
- Genetic ICM-203
Long term follow-up - Drug Placebo
Long term follow-up
Primary outcome measures
- Incidence of delayed adverse events [Time frame: Up to 5 years]
Secondary outcome measures (5)
- Knee pain [Time frame: Up to 3 years]
- Knee function [Time frame: Up to 3 years]
- Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) [Time frame: Up to 3 years]
- Joint space width [Time frame: Up to 3 years]
- Incidence of total knee replacement [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Previous receipt of ICM-203 or matching placebo
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Australia · 2 centers
- Royal Adelaide Hospital — Adelaide
- Barwon Health — Geelong
Identifiers
NCT: NCT05752032 · ICM 20-1002