BridgeMD
An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS
EU CTIS ID: 2023-507906-15-00
What this study is testing
Evaluate the long-term safety and tolerability of ofatumumab 20 mg sc once every 4 weeks in subjects with RMS from the first dose of ofatumumab
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have participated in a Novartis MS study: • which dosed ofatumumab 20 mg sc q4 weeks, • was an adult (≥ 18 years of age) study in RMS, • must have completed the study on study treatment
- 2. Written informed consent
You likely can't join if
- Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study
- Subjects that have had their previous ofatumumab study end of study (EOS) > 6 months prior to screening and/or been given another MS disease-modifying therapy (DMT) between EOS of previous study and screening of this study
- Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
- Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
- Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up (SFU) of the previous study during this time)
- Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects
See the full eligibility criteria
- Must have participated in a Novartis MS study: • which dosed ofatumumab 20 mg sc q4 weeks, • was an adult (≥ 18 years of age) study in RMS, • must have completed the study on study treatment
- 2. Written informed consent
- Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study
- Subjects that have had their previous ofatumumab study end of study (EOS) > 6 months prior to screening and/or been given another MS disease-modifying therapy (DMT) between EOS of previous study and screening of this study
- Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
- Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
- Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up (SFU) of the previous study during this time)
- Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects
- Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML
- Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))
- Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
- Taiwan
- United Kingdom
- Peru
- Australia
- Canada
- Turkey
- India
- Argentina
- Russian Federation
- Thailand
- Japan
- South Africa
- Israel
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States; Taiwan; United Kingdom; Peru; Australia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.