Status:
ACTIVE_NOT_RECRUITING
LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study duration of 4 years was considered to be sufficient to show a reliable and relevant effect of ocrelizumab on disability progression in the main study (CONSONANCE). However, given the potenti...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Able to comply with the study protocol, in the investigator's judgment
- Affiliation to the social security system
- Completed the treatment period of Roche-sponsored ocrelizumab trial (CONSONANCE) and who in the opinion of the investigator may benefit from treatment with ocrelizumab. Only patients enrolled under Protocol version 1 (approval date: 18 February 2018) will be eligible.
- Meet re-treatment criteria with ocrelizumab (please see section 6.11)
- Patients who became pregnant by chance between the last visit of the CONSONANCE study and screening of this study, as confirmed by pregnancy tests at screening, will enter the study but will only re-start treatment with ocrelizumab after birth or after breastfeeding is stopped, as per re-treatment criteria in section 6.11
- Women of childbearing potential\* (WOCBP):
- Must have a negative urine pregnancy test at Visit 1 (Screening) and Visit 2 (Baseline)
- Must agree to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet. The following contraceptive methods are considered acceptable (failure rate \>1% \[Clinical Trial Facilitation Group (CTFG)\]): (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% \[CTFG\]) 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) intrauterine hormone-releasing system; (5) bilateral tubal occlusion; (6) vasectomized partner; (7) sexual abstinence.
Exclusion
- Hypersensitivity to ocrelizumab or any of its excipients
- Patients in a severely immunocompromised state, until the condition resolves
- Evidence of any adverse event (AE) potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
- Existence of a contra-indication as per the Summary of Product Characteristics (SmPC)
- Prohibited concomitant medication as specified in section 6.7
- Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in CONSONANCE
- Patients who had early ocrelizumab discontinuation in CONSONANCE (exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in CONSONANCE)
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2029
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05210621
Start Date
March 8 2022
End Date
February 24 2029
Last Update
May 17 2024
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Amiens University Hospital
Amiens, France, 80051
2
Bayonne Hospital
Bayonne, France, 64100
3
Bordeaux University Hospital
Bordeaux, France, 33076
4
Caen University Hospital
Caen, France, 14033