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This is an observational study of the long term safety and efficacy of ICM-203.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICM-203 | Participants who previously received ICM-203 in ICM-203 clinical studies |
| |
| Placebo | Participants who previously received placebo in ICM-203 clinical studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICM-203 | Genetic | Long term follow-up |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delayed adverse events | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Knee pain | 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) | Up to 3 years |
| Knee function |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received ICM-203 or matching placebo in clinical studies
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| Name | Affiliation | Role |
|---|---|---|
| Alison Heald, MD | ICM Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Barwon Health |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
Long term follow-up |
|
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)
| Up to 3 years |
| Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS) | Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease | Up to 3 years |
| Joint space width | Evaluation of change from baseline in joint space width in mm as measured on knee radiograph | Up to 3 years |
| Incidence of total knee replacement | Up to 5 years |
| Geelong |
| Victoria |
| 3220 |
| Australia |