A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients
Public ClinicalTrials.gov record NCT03560739. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations
Study identification
- NCT ID
- NCT03560739
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 284 participants
Conditions and interventions
Conditions
Interventions
- ofatumumab with PRF Combination Product
- ofatumumab with AI Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 11, 2018 (Actual)
- Primary completion
- Aug 26, 2019 (Actual)
- Completion
- May 5, 2020 (Actual)
- Last update posted
- Oct 8, 2021
2018 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Fullerton | California | 92835 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Basalt | Colorado | 81621 | — |
| Novartis Investigative Site | Boulder | Colorado | 80301 | — |
| Novartis Investigative Site | Miami | Florida | 33136 | — |
| Novartis Investigative Site | Tampa | Florida | 33609 | — |
| Novartis Investigative Site | Tampa | Florida | 33612 | — |
| Novartis Investigative Site | West Palm Beach | Florida | 33407 | — |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | — |
| Novartis Investigative Site | Ozark | Missouri | 65721 | — |
| Novartis Investigative Site | Knoxville | Tennessee | 37922 | — |
| Novartis Investigative Site | Round Rock | Texas | 78681 | — |
| Novartis Investigative Site | Sherman | Texas | 75092 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03560739, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03560739 live on ClinicalTrials.gov.