B-cell Mediated Autoimmune Disorders
Conditions
Brief summary
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.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
TG Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
No
Inclusion criteria
1. Received at least 1 dose of azer-cel in TG-Azercel -101 study. 2. Signed informed consent form (ICF). 3. Willingness and ability to adhere to the study schedule and all other protocol requirements. Exclusion Citeria: 1\. No unique
Exclusion criteria
apply to this study.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 15 years | 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. |
| 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 | — |
Contacts
CONTACTTG Therapeutics Clinical Support Team
Outcome results
None listed