Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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18 October 2021 |
Main ID: |
NCT03560739 |
Date of registration:
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15/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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September 11, 2018 |
Target sample size:
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284 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03560739 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Bulgaria
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Czechia
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Estonia
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Latvia
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Lithuania
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Russian Federation
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Spain
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United States
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Combination Product: ofatumumab with PRF
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Combination Product: ofatumumab with AI
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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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]
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Percentage of Patients With Anti-ofatumumab Antibodies
[Time Frame: Baseline, Week 4, 8, 12 and Overall]
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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]
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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]
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Secondary ID(s)
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COMB157G2102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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