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Clinical trial

An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis

ID
Name
TG1101-RMS201E
Description
This study evaluates the long term use of a single agent ublituximab, a novel monoclonal antibody, in patients with relapsing forms of multiple sclerosis
Trial arms
Trial start
2017-06-01
Estimated PCD
2022-11-11
Trial end
2022-11-11
Status
Completed
Phase
Early phase I
Treatment
Ublituximab
Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
Arms:
Ublituximab
Other names:
TG1101
Size
48
Primary endpoint
Number of participants with treatment-related events as assessed by CTCAE V4.0
96 weeks on therapy
Eligibility criteria
Inclusion Criteria: * Subjects currently enrolled in TG1101-RMS201 trial * Subjects who have completed three infusions of ublituximab (at Day 1, Day 15, and Week24, as specified in the TG1101-RMS201 protocol) and have completed the scheduled assessments up to the final 48-week visit Exclusion Criteria: * Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101- RMS201 study during the 48-week evaluation period * Subjects who have started any other immunomodulating or disease modifying therapy after completion of the TG1101-RMS201 trial * Pregnant or nursing mothers
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2022-12-21

1 organization

1 product

1 indication

Organization
TG Therapeutics
Product
Ublituximab
Indication
Multiple Sclerosis