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

Study Sponsor: Novartis

Study Title

Medicine or Vaccine (generic name)

ofatumumab

Sponsor Identification Number

COMB157G2102

Trial Registry Identification Number(#'s)

NCT03560739

Medical Condition

Multiple Sclerosis

Phase

Phase 2

Link to study details on the Novartis Clinical Study Register

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17710

Link to study details on ClinicalTrials.gov (if available)

https://www.clinicaltrials.gov/ct2/show/NCT03560739?term=COMB157G2102&draw=2&rank=1

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=COMB157G2102

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

Date Added to this Site

February 2023