NCT03589105: PRO-MSACTIVE

A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

Completed Phase 4 Last updated 11 January 2022

What this trial tests

Phase 4 trial testing Ocrelizumab 300 mg in Multiple Sclerosis in 423 participants. Completed in 15 February 2021.

Timeline

6 August 2018

Primary endpoint
15 February 2021

15 February 2021

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	423
Start date	6 August 2018
Primary completion	15 February 2021
Estimated completion	15 February 2021
Sites	46 locations across France

Drugs / interventions tested

• Ocrelizumab 300 mg — full drug profile →
• Ocrelizumab 600 mg — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS. Participants will receive a maximum of 2 treatment cycles of ocrelizumab infusions: an initial dose of two 300 milligram (mg) infusions separated by 14 days followed by one single infusion of 600 mg ocrelizumab 24 weeks after the first infusion. Disease activity is determined by clinical relapses and/or Magnetic Resonance Imaging (MRI) activity.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy, safety and patient reported outcomes in patients with active relapsing multiple sclerosis treated with ocrelizumab: Final results from the PRO-MSACTIVE study.
   Manchon E, Laplaud D, Vukusic S, Labauge P, et al · · 2022 · cited 11× · PMID 36007299 · DOI 10.1016/j.msard.2022.104109
2. Interactive statistical monitoring to optimize review of potential clinical trial issues during study conduct.
   Pau D, Lotz M, Grandclaude G, Jegou R, et al · · 2023 · PMID 37008796 · DOI 10.1016/j.conctc.2023.101101