BridgeMD
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis
EU CTIS ID: 2023-506467-34-00
What this study is testing
To demonstrate the superiority of a higher dose of ocrelizumab over the approved dose of ocrelizumab as assessed by risk reduction in composite confirmed disability progression (cCDP) sustained for at least 12 weeks
- 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
- 1. Ages 18−55 years at time of screening
- 2. Diagnosis of RMS (i.e., RRMS or aSPMS where patients still experience relapses) in accordance with the revised McDonald Criteria 2017
- 3. At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening (with no relapse 30 days prior to screening and at baseline)
- 4. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments
- 5. Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive
- 6. Documented MRI of brain with abnormalities consistent with MS
You likely can't join if
- 1. History of primary progressive MS at screening
- 2. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
- 3. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- 4. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- 5. Immunocompromised state
- 6. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Canada
- Peru
- Bosnia and Herzegovina
- Australia
- Russian Federation
- Brazil
- Turkey
- Israel
- Mexico
- Belarus
- Ukraine
- United Kingdom
- Argentina
- United States
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; Canada; Peru; Bosnia and Herzegovina; Australia; Russian Federation and 9 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.