A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Conditions

Primary progressive multiple sclerosis (PPMS)

Brief summary

1. Time to onset of composite 12-week CDP defined as the time from randomization to the first occurrence of either 12-week CDP in 9-HPT, or 12-week CDP in EDSS

Detailed description

1. Time to 12-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 12 weeks, 2. Time to 24-week CDP in 9-HPT, 3. Time to 24-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 24 weeks, 4. Annual rate of percent change from baseline in total volume of T2 lesions, 5. Annual rate of percent change from Week 24 in total brain volume, 6. Incidence and nature of adverse events, serious adverse events, adverse events leading to study treatment withdrawal, 7. Change from baseline in laboratory test results for hematology and chemistry association of decrease in certain laboratory parameters, and serious infections, 8. Presence of ADA during the study relative to baseline, 9. Total plasma clearances (CL) of ocrelizumab, 10. Volumes of distribution(Vd) of ocrelizumab, 11. Area under the concentration-time curve (AUC) of ocrelizumab

Related papers

No related papers found yet.

Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion

DRUGPlacebo Ocrevus

DRUGDormutil N

DRUGMETHYLPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
1. Time to onset of composite 12-week CDP defined as the time from randomization to the first occurrence of either 12-week CDP in 9-HPT, or 12-week CDP in EDSS	—

Secondary

Measure	Time frame
1. Time to 12-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 12 weeks, 2. Time to 24-week CDP in 9-HPT, 3. Time to 24-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 24 weeks, 4. Annual rate of percent change from baseline in total volume of T2 lesions, 5. Annual rate of percent change from Week 24 in total brain volume, 6. Incidence and nature of adverse events, serious adverse events, adverse events leading to study treatment withdrawal, 7. Change from baseline in laboratory test results for hematology and chemistry association of decrease in certain laboratory parameters, and serious infections, 8. Presence of ADA during the study relative to baseline, 9. Total plasma clearances (CL) of ocrelizumab, 10. Volumes of distribution(Vd) of ocrelizumab, 11. Area under the concentration-time curve (AUC) of ocrelizumab	—

Measure

Time frame

1. Time to 12-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 12 weeks, 2. Time to 24-week CDP in 9-HPT, 3. Time to 24-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 24 weeks, 4. Annual rate of percent change from baseline in total volume of T2 lesions, 5. Annual rate of percent change from Week 24 in total brain volume, 6. Incidence and nature of adverse events, serious adverse events, adverse events leading to study treatment withdrawal, 7. Change from baseline in laboratory test results for hematology and chemistry association of decrease in certain laboratory parameters, and serious infections, 8. Presence of ADA during the study relative to baseline, 9. Total plasma clearances (CL) of ocrelizumab, 10. Volumes of distribution(Vd) of ocrelizumab, 11. Area under the concentration-time curve (AUC) of ocrelizumab

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Countries

Belgium, Bulgaria, Croatia, France, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed