BridgeMD
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis
EU CTIS ID: 2023-505980-36-00
What this study is testing
To evaluate the efficacy of ocrelizumab compared with placebo-in all randomized patients and in patients with MRI activity (MRI activity is defined as presence of T1 Gd+ lesion(s) and/or new and/or enlarging T2 lesion(s) as detected by MRI scans during the screening phase) on the basis of the following endpoint:Time to onset of composite 12-week CDP defined as the time from randomization to the first occurrence of at least one of the following progression events: 12-week CDP in 9-HPT, defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks 12-week CDP in EDSS score, defined as an increase of ≥ 1.0 point from baseline EDSS score in patients with a baseline EDSS score ≤ 5.5 or an increase of ≥0.5 point in patients with a baseline EDSS score of > 5.5 that is confirmed 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. Diagnosis of PPMS in accordance with the McDonald criteria (Thompson et al. 2017)
- 2. EDSS score at screening and baseline ≥ 3.0 to 8.0, inclusive
- 3. Disease duration from the onset of multiple sclerosis (MS) symptoms relative to randomization date: o Less than 20 years in patients with an EDSS score at screening 7.0-8.0 o Less than 15 years in patients with an EDSS at screening 5.5-6.5 o Less than 10 years in patients with an EDSS at screening ≤ 5.0
- 4. Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen o Elevated IgG index o One or more IgG oligoclonal bands detected by isoelectric focusing
- 5. Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)
- 6. Neurological stability for ≥ 30 days prior to baseline
You likely can't join if
- 1. History of relapsing-remitting or secondary progressive MS at screening
- 2. Confirmed serious opportunistic infection
- 3. Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy
- 4. Known active malignancy or are being actively monitored for recurrence of malignancy
- 5. Immunocompromised state defined as one or more of the following: CD4 count < 250/μL, absolute neutrophil count <1.5 x 103/μL, Serum IgG < 4.6 g/L
- 6. Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Serbia
- Canada
- Colombia
- Lebanon
- Russian Federation
- Belarus
- Australia
- Ukraine
- Tunisia
- United Kingdom
- Brazil
- New Zealand
- Mexico
- Morocco
- Georgia
- Egypt
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 United States; Serbia; Canada; Colombia; Lebanon; Russian Federation and 11 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.