A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Mul… (NCT04035005) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
United States1,013 participantsStarted 2019-08-12
Plain-language summary
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* EDSS score at screening and baseline \>= 3.0 to 8.0, inclusive
* Disease duration from the onset of MS symptoms relative to randomization date:
Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening \<= 5.0
* Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated immunoglobulin G (IgG) index or one or more IgG oligoclonal bands detected by isoelectric focusing
* Screening and baseline 9-HPT completed in \> 25 seconds (average of the two hands)
* Neurological stability for ≥ 30 days prior to baseline
* Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
* Neurological stability for \>/= 30 days prior to baseline
* Participants previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
* For female participants without reprodu…
What they're measuring
1
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS
Timeframe: Up to approximately 243 weeks
2
Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set