Health TrialsbyHealthPanel

Long-term Follow-up (LTFU) of Participants Who Received Azer-Cel

ConditionB-cell Mediated Autoimmune Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-62
SponsorTG Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Received at least 1 dose of azer-cel in TG-Azercel -101 study.

Signed informed consent form (ICF).

Willingness and ability to adhere to the study schedule and all other protocol requirements.

Disqualifiers

None

Trial population

Any participants receiving azer-cel in TG-Azercel -101 study will be enrolled in this LTFU study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    No Intervention

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Long-term Follow-up1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants With Clinically Significant CEI

Time frame
Up to 15 years
2

Number of Participants With Clinically Significant CEI Based on Severity

Time frame
Up to 15 years
3

Duration of Clinically Significant CEI

Time frame
Up to 15 years
4

Time to Onset of Clinically Significant CEI

Time frame
Up to 15 years

Secondary outcomes

1

Number of Participants With CEI and all Serious Adverse Events (SAEs)

Time frame
Up to 15 years
2

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.

Time frame
Up to 15 years
3

Duration of Disease Response Measured by Number of MS Relapses

Time frame
Up to 15 years
4

Duration of Disease Response Based on Number of T2 Lesions and Gd-enhancing T1 Lesions

Time frame
Up to 15 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TG Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: