BridgeMD
A Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Treatment in Patients with Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and without Access to A Post Trial Access Program
EU CTIS ID: 2023-507633-21-01
What this study is testing
To evaluate the physical impact of multiple sclerosis from a patient’s perspective and provide continued access to ocrelizumab
- 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. Signed extension study Informed Consent Form
- 2. Patients who were on ongoing ocrelizumab treatment on one of the following parent studies (Studies MN39159/CONSONANCE, BN42082/MUSETTE, BN42083/GAVOTTE, BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O’HAND, MN43964/OLERO, GN41791/FENTREPID, BP46016/ MINTAKA, CN41144/OCARINA I-SC, CN42097/OCARINA II-SC) at the time of roll-over and who do not have access to the ocrelizumab treatment locally
- 3. The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study
- 4. Ability to comply with the extension study protocol, per investigator’s judgement
- 5. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
- 6. Requirements for contraception and pregnancy testing For female participants of childbearing potential: : agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab Participants are considered to be of childbearing potential if they are postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements As defined by the guidelines, the following contraceptive methods are considered acceptable: (1) Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; (2) Male or female condom with or without spermicide; (3) Cap, diaphragm, or sponge with spermicide; (4) Combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier method) Birth control methods that are highly effective (i.e., failure rate <1%) may also be used but are not required, and include: (1) Oral, intravaginal, or transdermal combined hormonal contraception associated with inhibition of ovulation. (2) Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation. (3) Intrauterine device. (4) Intrauterinehormone-releasing system. (5) Bilateral tubal occlusion. (6) Vasectomized partner. (7) Sexual abstinence
You likely can't join if
- 1. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient
- 2. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient
- 3. Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- 4. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
- 5. Concurrent participation in any therapeutic clinical trial (other than the parent study)
- 6. Hypersensitivity to the active substance
The study team makes the final eligibility decision.
Where it's taking place
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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.