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NCT02545868 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT02545868: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02545868 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 102 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02545868, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
Primary Outcome
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Interventions
- BIOLOGICAL Influenza Vaccine
- BIOLOGICAL KLH
- BIOLOGICAL 23-PPV
- BIOLOGICAL 13-PCV Booster
- DRUG OCR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-10-27 |
| Est. Completion | 2021-09-21 |
| Phase | Phase 3 |
What the finished NCT02545868 record still lists
NCT02545868 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Influenza Vaccine is the first listed.
NCT02545868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02545868 about?
NCT02545868 is a clinical study titled "A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis". This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza va...
What is the current status of trial NCT02545868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2015-10-27. Estimated completion is 2021-09-21.
What interventions are being tested in trial NCT02545868?
The interventions under investigation include: Influenza Vaccine (BIOLOGICAL), KLH (BIOLOGICAL), 23-PPV (BIOLOGICAL), 13-PCV Booster (BIOLOGICAL), OCR (DRUG).
Who is sponsoring clinical trial NCT02545868?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02545868's enrollment target sits among peer trials
102 1676th of 2000 higher than 321 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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