A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis (NCT03523858) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
United States927 participantsStarted 2018-05-28
Plain-language summary
This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
* EDSS (Expanded Disability Status Scale) \</ =6.5 at screening
* Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
* Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
* Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug
Exclusion Criteria:
* Relapsing-remitting multiple sclerosis (RRMS) at screening
* Inability to complete an MRI
* Gadolinium (Gd) intolerance
* Known presence of other neurological disorders
Exclusions Related to General Health:
* Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
* Lactation
* Any concomitant disease that may require chronic treatment of systemi…
What they're measuring
1
Proportion of Participants with No Evidence of Progression (NEP)
Timeframe: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192
2
Proportion of Participants with no evidence of progression and no active disease (NEPAD)
Timeframe: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192