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NCT02637856 · ClinicalTrials.gov registry record · Phase 3
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
A Phase 3 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
- 20
- Study locations
NCT02637856: Completed Phase 3 study of Multiple Sclerosis (Relapsing Remitting), sponsored by Genentech.
NCT02637856 is a Phase 3 study of Multiple Sclerosis (Relapsing Remitting) that has completed, run by Genentech. The registered enrollment target is 608 participants, above the 542-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02637856, a Phase 3 study of Multiple Sclerosis (Relapsing Remitting), has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
Primary Outcome
Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.
Conditions Studied
Interventions
- DRUG Ocrelizumab
Study Locations (20)
California
- The Research Center of Southern California, LLC - Carlsbad
- Mercy Medical Group; MS Centre Nurse - Carmichael
- Fullerton Neurology and Headache Center - Fullerton
- Scripps Health - La Jolla
- UCSF- Multiple Sclerosis Centre; Department of Neurology - San Francisco
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Torrance
Colorado
- Mountain Neurological Research Center; Roaring Fork Neurologt, P.C. - Basalt
- IMMUNOe Research Centers - Centennial
- Colorado Neurological Institute - Englewood
- Advanced Neurology of Colorado, LLC - Fort Collins
Florida
- Neurology Associates PA - Maitland
- University of Miami Miller School of Medicine; Clinical Reseach Building - Miami
- Neurostudies Inc - Port Charlotte
- Infinity Clinical Research, LLC - Sunrise
Arizona
- Phoenix Neurological Associates Ltd - Phoenix
- Barrow Neurological Institute - Phoenix
- Territory Neurology and Research Institute - Tucson
Connecticut
- Associated Neurologists of Southern CT PC - Fairfield
- KI Health Partners, LLC; New England Institute for Clinical Research - Stamford
Alabama
- North Central Neurology Associates - Cullman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2016-02-11 |
| Est. Completion | 2019-05-03 |
| Phase | Phase 3 |
What the finished NCT02637856 record still lists
NCT02637856 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, above the 542-participant average among 29 other Multiple Sclerosis (Relapsing Remitting) trials with a reported enrollment target (12% higher).
The record links to 1 condition, with Multiple Sclerosis (Relapsing Remitting) appearing as the primary indexed condition, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT02637856 names 20 study sites across 6 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT02637856 about?
NCT02637856 is a clinical study titled "A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)". This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 day...
What is the current status of trial NCT02637856?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2016-02-11. Estimated completion is 2019-05-03.
What conditions does trial NCT02637856 study?
This clinical trial studies the following conditions: Multiple Sclerosis (Relapsing Remitting).
What interventions are being tested in trial NCT02637856?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT02637856?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02637856 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis (Relapsing Remitting)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02637856's enrollment target sits among peer trials
608 7th of 29 higher than 23 of 29 other Multiple Sclerosis (Relapsing Remitting) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis (Relapsing Remitting) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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