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Compares treatment options for Multiple Sclerosis
Official title Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial
ClinicalTrials.gov ID: NCT05999604
What this study is testing
What is Ocrelizumab Injection [Ocrevus]?
Ocrelizumab Injection [Ocrevus] is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and the leading cause of severe non-traumatic disability in young people, affecting 110,000 people in France. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the rate of new T2 lesions by 80% compared with interferon-β 1a.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient 18 years of age or older
- Presenting for a 4th semi-annual cycle of ocrelizumab (minimum)
- Requires follow-up MRI as part of treatment.
- Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form)
- Absence of relapse for at least 18 months (a relapse being defined as the appearance of new symptoms or worsening of existing symptoms, lasting more...
You likely can't join if
- Clinical forms of primary progressive MS
- Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart
- Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since...
- Planned pregnancy within 3 years
- Contraindication to MRI
- Contraindication to injection of contrast media
See the full eligibility criteria
- Patient 18 years of age or older
- Presenting for a 4th semi-annual cycle of ocrelizumab (minimum)
- Requires follow-up MRI as part of treatment.
- Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form)
- Absence of relapse for at least 18 months (a relapse being defined as the appearance of new symptoms or worsening of existing symptoms, lasting more than 24 hours and outside a period of fever or an infectious episode...
- EDSS between 0 and 6 inclusive
- Having received informed information about the study and having signed a consent to participate in the study
- French language proficiency
- Affiliated or beneficiary of a social insurance scheme
- Clinical forms of primary progressive MS
- Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart
- Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since previous injection, development of severe immune deficiency)
- Planned pregnancy within 3 years
- Contraindication to MRI
- Contraindication to injection of contrast media
- Subject with severe or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric or cardiac disease, or any uncontrolled intercurrent pathology.
- Patient under legal protection
- Patients of childbearing age who do not wish to use effective contraception
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
- Gonesse, France
- Grenoble, France
- Limoges, France
- Lyon, France
- Nice, France
- Paris, France
- Poissy, France
- Strasbourg, France
- Suresnes, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France; Gonesse, France; Grenoble, France; Limoges, France; Lyon, France; Nice, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.