World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 October 2021
Main ID:  NCT03560739
Date of registration: 15/05/2018
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: 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
Scientific title: 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
Date of first enrolment: September 11, 2018
Target sample size: 284
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03560739
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Austria Bulgaria Czechia Estonia Latvia Lithuania Russian Federation Spain
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of multiple sclerosis (MS)

- Relapsing MS: relapsing-remitting course (RRMS), or Secondary progressive (SPMS)
course

- EDSS score of 0 to 5.5

- Documentation of at least: 1 relapse during the previous year OR 2 relapses during the
previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the
year prior to randomization.

- Neurologically stable within 1 month prior to randomization

Exclusion Criteria:

- Patients with primary progressive MS or SPMS without disease activity

- Disease duration of more than 10 years in patients with EDSS score of 2 or less

- Patients with an active chronic disease of the immune system other than MS

- Patients with active systemic bacterial, viral or fungal infections, or known to have
AIDS or to test positive for HIV antibody at Screening

- Patients with neurological findings consistent with Progressive Multifocal
Leukoencephalopathy (PML), or confirmed PML



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Combination Product: ofatumumab with AI
Combination Product: ofatumumab with PRF
Primary Outcome(s)
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by AUCtau [Time Frame: Week 8 to Week 12 dosing interval]
Bioequivalence of 20 mg Ofatumumab Injected by Pre-filled Syringe (PFS) vs Autoinjector (AI) to Abdomen as Measured by Cmax [Time Frame: Week 8 to Week 12 dosing interval]
Secondary Outcome(s)
Pharmacokinetics of the Study Drug as Measured by AUCtau for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Week 8 to Week 12 dosing interval]
Plasma Concentrations of the Study Drug for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Days 4, 7, 14, 28, 42, 56, 57, 59, 63, 70, 77, 84]
Percentage of Patients With Anti-ofatumumab Antibodies [Time Frame: Baseline, Week 4, 8, 12 and Overall]
Pharmacokinetics of the Study Drug as Measured by Cmax for PFS and AI Devices When Administered to Abdomen or Thigh [Time Frame: Week 8 to Week 12 dosing interval]
Secondary ID(s)
COMB157G2102
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 09/10/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03560739
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey