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Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls. (AGNOS)

Primary Purpose

Relapse Remitting Multiple Sclerosis

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ofatumumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse Remitting Multiple Sclerosis focused on measuring early relapsing multiple sclerosis, ofatumumab, healthy control, treatment naïve, young adult population, MS-related disability, biomarker, MRI

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Signed informed consent must be obtained prior to participation in the study

  2. Age 18-35 years

    Patients in the healthy control arm eligible for inclusion must fulfill the following criteria:

  3. Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device

  4. Able to provide blood sample (no CSF will be collected in HC)

    Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria:

  5. Diagnosis of RRMS per McDonald Criteria (2010/2017)
  6. Within 6 months of diagnosis of clinically definite MS (CDMS)
  7. EDSS 0-3.0 (Inclusive)
  8. Treatment-naïve to MS DMT
  9. Able to obtain MRI and attend study visits at sites
  10. Able to use wearable device
  11. Able to provide blood sample (and CSF for sub-group n=15)

Key Exclusion Criteria:

Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study:

  1. Confounding medical condition as determined by the investigator

    RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study:

  2. Diseases other than multiple sclerosis responsible for the clinical or MRI presentation
  3. Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis
  4. Use of experimental or investigational drugs for MS
  5. Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS
  6. Relapse between screening and Baseline visits
  7. Known sensitivity to gadolinium; patients with chronic, severe kidney disease
  8. Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
  9. CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments
  10. Known active malignancies
  11. Pregnant or nursing (lactating) women
  12. Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab
  13. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome
  14. Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening
  15. Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML
  16. Patients with IgG or IgM levels below LLN at Screening
  17. Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration
  18. Patients at risk of developing or having reactivation of hepatitis

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ofatumumab

Healthy Control

Arm Description

Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30.

Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment.

Outcomes

Primary Outcome Measures

Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 6 to 18.

Secondary Outcome Measures

Number of relapses
Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS performed by the EDSS Rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Confirmation of MS relapse based on these definitions will be done centrally.
Number of participants that were 3-month Disability Worsening-free
No increase or worsening of disability over a period of 3 months or more
Number of participants with NEDA (No Evidence of Disease Activity) - Clinical
A participant is considered as achieved NEDA-Clinical if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery).
Number of participants with NEDA (No Evidence of Disease Activity) - Radiological
A participant is considered as achieved NEDA-radiological if the participant has has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 6 to 18.
Change from Baseline in Gd+ lesion count
Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Change from Baseline in Gd+ lesion volume
Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Change from Baseline in new/enlarging T2 lesion count
Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Change from Baseline in T2 lesion volume
Change in size of T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Change from Baseline for NeuroQOL
The NeuroQOL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following domains will be measured. Physical Health, Mental Health, Social Health. Scales can be scored by summing the values of the response to each item to develop a total raw score.
Change from Baseline for Patient Determined Disease Steps (PDDS)
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in multiple sclerosis patients primarily based on ambulation. The questionnaire contains 1 question which is scored ranging from 0 (normal) to 8 (bedridden). A score of 0 to 2 indicates mild disability; a score of 3 to 5 indicates moderate disability; a score of 6 to 8 indicates severe disability.
Brain volume loss (BVL) assessment (whole brain and regional)
Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression. Evaluate the effect of ofatumumab vs healthy controls on 1) whole brain and regional atrophy measured at month 18/30 after re-baseline at 6 months; and 2) regional atrophy measured 18/30 months from Baseline
Number of participants with treatment emergent adverse events
Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration > the participant's baseline value or > the lower limit of normal, whichever is observed first. Other safety assessments (physical exam, vital signs, etc) that meet the definition of an adverse event or are considered clinically relevant by the investigator will be reported as an adverse event.

Full Information

First Posted
October 7, 2021
Last Updated
July 11, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05084638
Brief Title
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
Acronym
AGNOS
Official Title
AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
February 21, 2025 (Anticipated)
Study Completion Date
June 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
Detailed Description
The study is an open-label, multi-center, prospective 18-month study in 118 MS participants with early RRMS (defined as within 6 months of diagnosis of clinically definite RRMS) and who are treatment naïve. It is designed to determine if RRMS participants treated with 20 mg subcutaneous monthly ofatumumab during the earliest part of their disease will benefit from the use of ofatumumab as their first disease modifying therapy. Additionally, RRMS patients will be compared to age- and sex-matched healthy participants (n=50) for select outcomes to observe similarities and differences between the groups. After giving consent, participants will have a 28-day screening/qualification period. If they qualify to continue, they will start study measures including assessments of clinical and magnetic resonance imaging (MRI) metrics and use of a digital monitoring watch. Additionally, samples will be collected for laboratory and biomarker analysis. RRMS participants will begin treatment with ofatumumab for the next 18 months. Healthy participants will undergo similar assessments; however they will not receive any treatment during the course of the study. Over the 18 months, participants will have regular clinical visits with assessments and sample collection. After 18 months in the trial, participants in both groups will have the option to enter into a 12-month extension (up to 30 months total in study) to collect further information on long-term clinical and MRI outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse Remitting Multiple Sclerosis
Keywords
early relapsing multiple sclerosis, ofatumumab, healthy control, treatment naïve, young adult population, MS-related disability, biomarker, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ofatumumab
Arm Type
Experimental
Arm Description
Ofatumumab will be provided in an autoinjector for subcutaneous administration. Dosing regimen for this study is an initial dose of 20mg at Baseline/Week 0, followed by Week 1, 2 and every month thereafter, beginning at Week 4 (Month 1) until Month 18. There will be an optional extension of dosing through month 30.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
Healthy Control arm will be age- and sex-matched subjects (to the ofatumumab treated arm) and will not receive a study treatment.
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
OMB157
Intervention Description
20mg subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)
Description
A participant is considered as achieved NEDA-3 if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery), has not had an increase in disability and has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 6 to 18.
Time Frame
Month 6 to month 18
Secondary Outcome Measure Information:
Title
Number of relapses
Description
Relapses are recurrences of a disease activity after a recovery. A confirmed MS relapse is one accompanied by a clinically relevant change in the EDSS performed by the EDSS Rater, i.e. an increase of at least 0.5 points on the EDSS score, or an increase of 1 point on two functional scores (FSs) or 2 points on one FS, excluding changes involving bowel/bladder or cerebral FS compared to the previous available rating (the last EDSS rating that did not occur during a relapse). Confirmation of MS relapse based on these definitions will be done centrally.
Time Frame
Baseline to Month 18 and 30
Title
Number of participants that were 3-month Disability Worsening-free
Description
No increase or worsening of disability over a period of 3 months or more
Time Frame
Baseline up to Month 18 and 30
Title
Number of participants with NEDA (No Evidence of Disease Activity) - Clinical
Description
A participant is considered as achieved NEDA-Clinical if the participant has not had a clinical relapse (recurrence of a disease activity after a recovery).
Time Frame
Month 6 to Month 18
Title
Number of participants with NEDA (No Evidence of Disease Activity) - Radiological
Description
A participant is considered as achieved NEDA-radiological if the participant has has no new radiological MRI activity (no new occurrences of contrast-enhancing lesions) during study Months 6 to 18.
Time Frame
Month 6 to Month 18
Title
Change from Baseline in Gd+ lesion count
Description
Change in the number of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Time Frame
Baseline to Month 18 and 30
Title
Change from Baseline in Gd+ lesion volume
Description
Change in size of gadolinium enhancing lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Time Frame
Baseline to Month 18 and 30
Title
Change from Baseline in new/enlarging T2 lesion count
Description
Change in the number of new/enlarging T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Time Frame
Baseline to Month 18 and 30
Title
Change from Baseline in T2 lesion volume
Description
Change in size of T2 lesions will be measured by Magnetic Resonance Imaging (MRI). Each MRI scan will be previewed by a local neuroradiologist. The quality of each scan performed will be assessed by a central MRI reading center.
Time Frame
Baseline to Month 18 and 30
Title
Change from Baseline for NeuroQOL
Description
The NeuroQOL is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following domains will be measured. Physical Health, Mental Health, Social Health. Scales can be scored by summing the values of the response to each item to develop a total raw score.
Time Frame
Baseline to Month 18 and 30
Title
Change from Baseline for Patient Determined Disease Steps (PDDS)
Description
The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in multiple sclerosis patients primarily based on ambulation. The questionnaire contains 1 question which is scored ranging from 0 (normal) to 8 (bedridden). A score of 0 to 2 indicates mild disability; a score of 3 to 5 indicates moderate disability; a score of 6 to 8 indicates severe disability.
Time Frame
Baseline to Month 18 and 30
Title
Brain volume loss (BVL) assessment (whole brain and regional)
Description
Brain volume loss is a marker of progressive loss of brain structure and function. It is a predictor of disability progression. Evaluate the effect of ofatumumab vs healthy controls on 1) whole brain and regional atrophy measured at month 18/30 after re-baseline at 6 months; and 2) regional atrophy measured 18/30 months from Baseline
Time Frame
Month 6 to Month 18 and 30
Title
Number of participants with treatment emergent adverse events
Description
Adverse event monitoring should be continued following the last dose of study treatment until B cells are repleted. Repletion is defined as a concentration > the participant's baseline value or > the lower limit of normal, whichever is observed first. Other safety assessments (physical exam, vital signs, etc) that meet the definition of an adverse event or are considered clinically relevant by the investigator will be reported as an adverse event.
Time Frame
Baseline up to approximately Month 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study Age 18-35 years Patients in the healthy control arm eligible for inclusion must fulfill the following criteria: Able to obtain MRI (HC with abnormal MRI at Screening will be excluded) and use wearable device Able to provide blood sample (no CSF will be collected in HC) Patients in the ofatumumab-treated arm eligible for inclusion must fulfill the following criteria: Diagnosis of RRMS per McDonald Criteria (2010/2017) Within 6 months of diagnosis of clinically definite MS (CDMS) EDSS 0-3.0 (Inclusive) Treatment-naïve to MS DMT Able to obtain MRI and attend study visits at sites Able to use wearable device Able to provide blood sample (and CSF for sub-group n=15) Key Exclusion Criteria: Participants in the healthy control arm meeting any of the following criteria are not eligible for inclusion in this study: Confounding medical condition as determined by the investigator RRMS patients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study: Diseases other than multiple sclerosis responsible for the clinical or MRI presentation Patients with neuromyelitis optica, Radiologic/ Clinically Isolated Syndrome, Secondary Progressive or Primary Progressive MS diagnosis Use of experimental or investigational drugs for MS Previous use of Disease Modifying Therapy (DMT) or chemotherapeutic medications for MS Relapse between screening and Baseline visits Known sensitivity to gadolinium; patients with chronic, severe kidney disease Known history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes CNS anomalies that are better accounted for by another disease process or MRI anomalies causing clinically apparent impairments Known active malignancies Pregnant or nursing (lactating) women Females of childbearing potential (all women physiologically capable of becoming pregnant) should use effective contraception while receiving ofatumumab and for 6 months after the last treatment of ofatumumab Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with immunodeficiency syndrome Patients with active infections including systemic bacterial, viral (including SARS-CoV-2/COVID-19) 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 Patients with IgG or IgM levels below LLN at Screening Patients that have received any live or live-attenuated vaccines within 4 weeks prior to first dose of study drug administration Patients at risk of developing or having reactivation of hepatitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Facility Information:
Facility Name
Novartis Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509-2910
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32714
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jefferson
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89521
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9034
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

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