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The main objective of this study is to collect data on the long-term safety of azer-cel, primarily through the capture of clinical events of interest (CEI) for up to 15 years following participation in TG-Azercel -101 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-term Follow-up | Participants who received azer-cel in TG-Azercel -101 study will be followed-up for a total of 15 years until withdrawal of consent, lost to follow-up, or until death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant CEI | Up to 15 years | |
| Number of Participants With Clinically Significant CEI Based on Severity | Up to 15 years | |
| Duration of Clinically Significant CEI | Up to 15 years | |
| Time to Onset of Clinically Significant CEI | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With CEI and all Serious Adverse Events (SAEs) | Up to 15 years | |
| Duration of Disease Response Measured by Expanded Disability Status Scale (EDSS) Scores | The EDSS is a standardized tool used to measure disability in participants with multiple sclerosis (MS). The EDSS scores range from 0 to 10, based on the severity of disability. Higher score indicates severity of disability. |
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Inclusion Criteria:
Exclusion Citeria:
1. No unique exclusion criteria apply to this study.
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Any participants receiving azer-cel in TG-Azercel -101 study will be enrolled in this LTFU study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TG Therapeutics Clinical Support Team | Contact | 1-877-575-8489 | clinicalsupport@tgtxinc.com |
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| Up to 15 years |
| Duration of Disease Response Measured by Number of MS Relapses | Up to 15 years |
| Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions | Up to 15 years |