## Protocol Section
### Identification Module
**NCT ID:** NCT05576779

**Brief Title:** Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.

**Official Title:** Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World

#### Organization Study ID Info
**ID:** COMB157GUS11
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2020-12-03

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2022-10-13
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-10
**Study First Submit QC Date:** 2022-10-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novartis Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.

**Detailed Description:** The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.

Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.

The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

**Keywords:**

- Multiple sclerosis,

- ofatumumab,

- disease-modifying therapy,

- COVID-19

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2101

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** all eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

**Intervention Names:**

- Other: Ofatunumab

**Label:** Ofatumumab

#### Arm Group 2

**Description:** patients with no evidence of ofatumumab during the index period were included in the non-ofatumumab cohort and included in subgroups based on the index medication: Siponimod, Ocrelizumab, Dimethyl fumarate, Glatiramer acetate

**Label:** Non-ofatumumab

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ofatumumab

**Description:** All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

**Name:** Ofatunumab

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.

**Measure:** Proportion of patients initiating ofatumumab based on DMT use

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

#### Secondary Outcomes

**Description:** Age information was reported

**Measure:** Age

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Gender information was reported

**Measure:** Gender

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Northeast, Midwest, South, West, Unknown

**Measure:** Number of patients: Geographic region

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** The geographical heat map of ofatumumab utilization at the state level was presented.

**Measure:** Number of patients: State level (Geographic region)

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Cash, Commercial, Medicare, Medicare Part D, Medicaid, Unknown

**Measure:** Number of patients: Insurance type

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** CVS, Aetna etc

**Measure:** Number of patients: Payer

**Time Frame:** Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Ofatumumab persistence was assessed over the variable follow-up time.

**Measure:** Follow-up time

**Time Frame:** Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. omorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2)

**Measure:** Number of patients: Pre-index Charlson comorbidity index (CCI)

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with list of comorbidities were reported

**Measure:** Number of patients: Pre-index comorbidities

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with MS relapses were reported

**Measure:** Number of patients with a relapse in inpatient settings

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with MS relapses were reported

**Measure:** Number of patients with a relapse in outpatient settings

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with MS relapses were reported

**Measure:** Number of relapses in all patients

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with MS relapses were reported

**Measure:** Number of relapses in patients with at least 1 relapse

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Pre-index MS-related symptoms and secondary conditions (n, %) based on a Claims-Based Disability Score (e.g., sensory problems, eye symptoms, pyramidal symptoms, bladder/bowel symptoms, fatigue/malaise, muscular weakness, durable medical equipment utilization.

**Measure:** Claims-Based Disability Score

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Categorized as: No MRI, 1, 2, 3+

**Measure:** Number of pre-index Brain and Spinal MRI scans

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Number of patients: Hepatitis B virus screening

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Number of patients: Quantitative serum immunoglobulin screening

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Number of patients: Pre-index flu shot

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Number of patients: Post-index flu shot

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Yes/No

**Measure:** Pre-index: Number of patients with COVID-19 diagnosis

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Post-index: Number of patients with COVID-19 diagnosis

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Days between COVID-19 diagnosis and initiation of ofatumumab were reported

**Measure:** Days between COVID-19 diagnosis and initiation of ofatumumab

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Yes/No

**Measure:** Pre-index: Number of patients with COVID-19 vaccination

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Yes/No

**Measure:** Post-index: Number of patients with COVID-19 vaccination

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Days between COVID-19 vaccination and initiation of ofatumumab were reported.

**Measure:** Days between COVID-19 vaccination and initiation of ofatumumab

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** E.g. diphenhydramine, dexamethasone and other steroids. pre-medication was defined as medication observed within two days of ofatumumab initiation.

**Measure:** Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Number of patients with an inpatient visits were reported to report the pre-index healthcare resource utilization

**Measure:** Pre-index HCRU: Number of patients with an inpatient visit

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with an ED visit were reported to report the pre-index healthcare resource utilization

**Measure:** Pre-index HCRU: Number of patients with an ED visit

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with an outpatient visit were reported to report the pre-index healthcare resource utilization

**Measure:** Pre-index HCRU: Number of patients with an outpatient visit

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with a pharmacy claim were reported to report the pre-index healthcare resource utilization

**Measure:** Pre-index HCRU: Number of patients with a pharmacy claim

**Time Frame:** 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

**Description:** Number of patients with an inpatient visits were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

**Measure:** Post-index HCRU: Number of patients with an inpatient visit

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Number of patients with an ED visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

**Measure:** Post-index HCRU: Number of patients with an ED visit

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Number of patients with an outpatient visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

**Measure:** Post-index HCRU: Number of patients with an outpatient visit

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

**Description:** Number of patients with a pharmacy claim were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

**Measure:** Post-index HCRU: Number of patients with a pharmacy claim

**Time Frame:** Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.

  -. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.
* Patients with linkage to the Dx database.

Exclusion criteria

- No exclusion criteria were applied to patients in the study.

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with prescription claims for ofatumumab or other DMTs of interest.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** East Hanover

**Country:** United States

**Facility:** Novartis Investigative Site

**State:** New Jersey

**Zip:** 07936-1080

#### Overall Officials

**Official 1:**

**Affiliation:** Novartis Pharmaceuticals

**Name:** Novartis Pharmaceuticals

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Results for COMB157GUS11 from the Novartis Clinical Trials Website

**URL:** http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17981

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M2561

- Name: COVID-19

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M347498

- Name: Ofatumumab

- Relevance: LOW

- As Found: Unknown

- ID: M288908

- Name: Ocrelizumab

- Relevance: LOW

- As Found: Unknown

- ID: M297

- Name: Glatiramer Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M147897

- Name: (T,G)-A-L

- Relevance: LOW

- As Found: Unknown

- ID: M431

- Name: Dimethyl Fumarate

- Relevance: LOW

- As Found: Unknown

- ID: M271068

- Name: Siponimod

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
