Informations générales (source: ClinicalTrials.gov)
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 (WINDOCRE)
Interventional
Phase 3
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
novembre 2023
novembre 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Caroline BENSA | 21/06/2024 13:35:06 | Contacter | ||
Critères
Tous
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
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
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