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NotablePrimary completion pushed from May 1, 2030 to Aug 25, 2031Enrollment closed, study ongoing · Completion pushed from Nov 1, 2030 to Feb 25, 2032 · Site details revised at 13 of 13 sitesv24Show 3 more changesShow less
Enrollment closed, study ongoing
Completion pushed from Nov 1, 2030 to Feb 25, 2032
Site details revised at 13 of 13 sites
MinorStart date: Jan 12, 2023 to Feb 7, 2023Site contacts updated at 3 of 13 sitesv23Show 1 more changeShow less
Site contacts updated at 3 of 13 sites
MinorStudy sites: 12 to 13v22
MinorSite contacts updated at 1 of 12 sitesv21
MinorSite contacts updated at 1 of 12 sitesv20
Show 18 earlier versionsHide 18 earlier versions
MinorStudy sites: 11 to 12v19
MinorEligibility criteria expanded, about 78 wordsStudy description expanded, about 14 wordsv18Show 1 more changeShow less
NotablePrimary completion date: Aug 1, 2028 to May 1, 2030Completion date: Aug 1, 2028 to Nov 1, 2030 · Site details revised at 6 of 11 sitesv17Show 2 more changesShow less
Completion date: Aug 1, 2028 to Nov 1, 2030
Site details revised at 6 of 11 sites
MinorSecondary endpoints: details revised at 2 of 7 entriesSite details revised at 1 of 11 sitesv16Show 1 more changeShow less
Site details revised at 1 of 11 sites
MinorStudy sites: 12 to 11v15
MinorEnrollment target: 175 to 123Secondary endpoints revised (7) · Site contacts updated at 5 of 12 sites · Study arms: 3 to 2 · 2 morev14Show 5 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Dec 16, 2022 to Jan 12, 2023 · Site details revised at 10 of 10 sitesv7Show 2 more changesShow less
Start date changed from estimate of Dec 16, 2022 to Jan 12, 2023
Site details revised at 10 of 10 sites
NotableStart date: Oct 31, 2022 to Dec 16, 2022Primary endpoints: 3 to 1 · Study sites: 12 to 10 · Interventions: Ocrelizumab (Biological), Placebo for Ocrelizumab (Drug) to Ocrelizumab (Drug), Placebo for Ocrelizumab (Drug) · 3 morev6Show 6 more changesShow less
Primary endpoints: 3 to 1
Study sites: 12 to 10
Interventions: Ocrelizumab (Biological), Placebo for Ocrelizumab (Drug) to Ocrelizumab (Drug), Placebo for Ocrelizumab (Drug)
NotableStart date: Apr 30, 2022 to Jul 1, 2022Primary and study completion dates: Apr 30, 2028 to Jul 1, 2028 · Secondary endpoints: details revised at 1 of 7 entriesv2Show 2 more changesShow less
Primary and study completion dates: Apr 30, 2028 to Jul 1, 2028
Secondary endpoints: details revised at 1 of 7 entries
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.