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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

Study Purpose

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. The use of anti-CD20 agents, including ocrelizumab, is associated with an infectious risk that increases with duration of exposure, part of which is due to the development of hypo-gammaglobulinemia in relation to cumulative dose. Several reports suggest a persistent effect of anti-CD20 drugs in MS, with no resumption of inflammatory activity after discontinuation:

- During the development of ocrelizumab, at the end of phase 2, after having received 3 or 4 semi-annual cycles of ocrelizumab, a safety period with a therapeutic window of 18 months was planned, before re-administration in the extension study.

During this therapeutic window, the annualized relapse rate remained stable, and patients showed no radiological disease activity.

- Scandinavian observational studies of "off-label" use of anti-CD20 in MS provide real-life evidence of the absence of recovery of clinical and radiological activity after prolonged interruption of treatment.

After 2 years of treatment, and with disease activity under control, spacing administration intervals could reduce the risk of infection without reducing treatment efficacy. This would facilitate the decision to maintain highly active immunotherapy over the long term. In addition, this therapeutic de-escalation, by reducing the frequency of infusions and associated day hospitalizations, would help to reduce treatment management costs. Our aim is to evaluate the non-inferiority of 12-monthly spacing of ocrelizumab infusions versus the conventional 6-monthly regimen, in a population of active MS patients over 18 years of age who have already received 4 or more semi-annual cycles of treatment for 2 years.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient 18 years of age or older. 2. Presenting for a 4th semi-annual cycle of ocrelizumab (minimum) 3. Requires follow-up MRI as part of treatment. 4. Initial indication for ocrelizumab according to the marketing authorization (active MS, RR or SP form) 5. 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; notified as a validated relapse by the neurologist in the patient's file, treated or not with boluses of Solu-Medrol). 6. EDSS between 0 and 6 inclusive. 7. Having received informed information about the study and having signed a consent to participate in the study. 8. French language proficiency. 9. Affiliated or beneficiary of a social insurance scheme.

Exclusion Criteria:

1. Clinical forms of primary progressive MS. 2. Patients already receiving systematically spaced doses of ocrelizumab ≥ 9 months apart. 3. Contraindication to continued treatment with ocrelizumab (hypersensitivity reaction, ongoing active infection, development of malignancy since previous injection, development of severe immune deficiency) 4. Planned pregnancy within 3 years. 5. Contraindication to MRI. 6. Contraindication to injection of contrast media. 7. Subject with severe or uncontrolled symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric or cardiac disease, or any uncontrolled intercurrent pathology. 8. Patient under legal protection. 9. Patients of childbearing age who do not wish to use effective contraception. 10. Pregnant or breast-feeding women

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05999604
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: annual ocrelizumab infusions

Other: semestrial ocrelizumab infusions

Interventions

Drug: - Ocrelizumab Injection [Ocrevus]

Semestrial administration

Drug: - Ocrelizumab Injection [Ocrevus]

Annual administration

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If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fondation Adolphe de Rothschild, Paris, France

Status

Recruiting

Address

Fondation Adolphe de Rothschild

Paris, , 75019

Site Contact

Dr BENSA

[email protected]

0148036753

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