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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03650114




Registration number
NCT03650114
Ethics application status
Date submitted
17/08/2018
Date registered
28/08/2018

Titles & IDs
Public title
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Scientific title
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Secondary ID [1] 0 0
COMB157G2399
Universal Trial Number (UTN)
Trial acronym
ALITHIOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ofatumumab
Treatment: Other - Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Treatment: Other - 13-valent pneumococcal conjugate vaccine (13-PCV)
Treatment: Other - 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Treatment: Other - Seasonal Quadrivalent influenza vaccine
Treatment: Other - Keyhole limpet hemocyanin (KLH) neo-antigen

Experimental: Ofatumumab - Subcutaneous injection


Treatment: Other: Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks

Treatment: Other: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Treatment: Other: 13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe

Treatment: Other: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe

Treatment: Other: Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

Treatment: Other: Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Timepoint [1] 0 0
Up to 8 years
Secondary outcome [1] 0 0
Number of relapse rates per year
Timepoint [1] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [2] 0 0
Patients with confirmed 3 and 6 month disability worsening
Timepoint [2] 0 0
During the first 5 years of treatment in the study.
Secondary outcome [3] 0 0
Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.
Timepoint [3] 0 0
During the first 5 years of treatment in the study.
Secondary outcome [4] 0 0
Patients with changes in Expanded Disability Status Scale (EDSS) scores
Timepoint [4] 0 0
Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization)
Secondary outcome [5] 0 0
Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
Timepoint [5] 0 0
During the first 5 years of the study.
Secondary outcome [6] 0 0
Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
Timepoint [6] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [7] 0 0
Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
Timepoint [7] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [8] 0 0
Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
Timepoint [8] 0 0
Data from the core studies through the first 5 years in this study.
Secondary outcome [9] 0 0
Changes in neurofilament light change serum concentration
Timepoint [9] 0 0
Data from the core studies through the first 5 years in this study.

Eligibility
Key inclusion criteria
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
2. Written informed consent
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
* Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
* Subjects taking medications prohibited by the protocol
* Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

1. Informed consent
2. Actively enrolled in the COMB157G2399 Study
3. 12 weeks of continuous treatment within the COMB157G2399 Study
4. prior vaccination history as per protocol-defined

Exclusion criteria

* known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
* allergies to egg or shellfish
* any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
* any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2028
Actual
Sample size
Target
2060
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [2] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Novartis Investigative Site - St Leonards
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
Novartis.email@novartis.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03650114