Status:

RECRUITING

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

Lead Sponsor:

Fondation Ophtalmologique Adolphe de Rothschild

Conditions:

Multiple Sclerosis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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. Ocre...

Eligibility 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

Key Trial Info

Start Date :

November 9 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2029

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT05999604

Start Date

November 9 2023

End Date

November 1 2029

Last Update

January 21 2026

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Hôpital Henri Mondor

Créteil, France, 94010

2

CH Gonesse

Gonesse, France, 95500

3

CHU de Grenoble

Grenoble, France, 38043

4

CHU de Limoges

Limoges, France, 87042

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 | DecenTrialz