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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05266469
Other study ID # COMB157GAE01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 26, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either Ofatumumab or Ocrelizumab that will be recruited and followed up for one year to collect their profiles across the Gulf countries.


Description:

This study will be conducted retrospectively (for patients who had their first treatment initiated on either Ofatumumab or Ocrelizumab before study start and from 2019 onwards) and prospectively (for patients who are initiated on either drug during the active recruitment period which spans for one year after the start of the first data collection) using data collected in a standardized manner. Index date (baseline): Defined as the date of the first treatment initiated on either Ofatumumab or Ocrelizumab Index period: The patients fulfilling the inclusion criteria will be identified during the recruitment period (01-Jan-2019 to 01-April-2023 or up to 1 year after the start of the active recruitment period).


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Males and Females. - Age 18 to 65 years. - Confirmed RMS diagnosis as per the 2017 updated McDonald's criteria (Thompson et al., 2018). - Having their first dose of either drugs during the index period (2019 onwards and up to 1 year since start of the active recruitment period). - The decision to initiate either drug should be based on the patient's disease and taken by the treating physician before the decision of inviting the patient to participate in the study. - The patient agreed and provided informed consent on the use of his/her de-identified data. Exclusion Criteria: - Patients below 18 years or above 65 years. - Pregnant females. - SPMS and/or PPMS patients. - The patient's refusal to be included in the study.

Study Design


Intervention

Other:
Ofatumumab
There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
Ocrelizumab
There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Locations

Country Name City State
Oman Novartis Investigative Site Muscat
United Arab Emirates Novartis Investigative Site Abu Dhabi
United Arab Emirates Novartis Investigative Site Abu Dhabi
United Arab Emirates Novartis Investigative Site Al Ain Abu Dhabi
United Arab Emirates Novartis Investigative Site Dubai
United Arab Emirates Novartis Investigative Site Sharjah

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Oman,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expanded Disability Status Scale (EDSS) EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS Baseline
Primary Magnetic Resonance Imaging (MRI) activity number of participants with:
T1-Gd+
absence of T1-Gd+
T2 lesions
Baseline
Primary Volume of T2 lesions Volume of T2 lesions will be provided Baseline
Primary Number of relapses in the past 12 months Number of relapses in the past 12 months will be collected. Relapse is defined as the occurrence of new symptoms or the worsening of old symptoms that happens during the Multiple Sclerosis course Baseline
Primary Baseline ARR (Annualized Relapse Rates) Baseline ARR (Annualized Relapse Rates) will be collected Baseline
Primary Time since MS diagnosis Time since Multiple Sclerosis (MS) diagnosis will be provided Baseline
Primary Time since first MS symptom Time since first Multiple Sclerosis (MS) symptom will be collected Baseline
Primary Percentage of participants with previous DMTs Percentage of participants with previous Disease modifying therapies (DMTs) will be collected Baseline
Primary Time from diagnosis to start of treatment Time from diagnosis to start of treatment will be collected Baseline
Primary Number of previous DMT treatment Number of previous DMT treatment will be collected Baseline
Primary Line of previous DMT treatment Line of previous DMT treatment will be collected Baseline
Primary Type of previous DMT Type of previous DMT will be collected:
Any interferon beta
Glatiramer acetate
Dimethyl fumarate
Teriflunomide
Fingolimod
Natalizumab
Cladribine
Alemtuzumab
Other B-cell therapy (Rituximab)
Other disease-modifying therapy
Baseline
Primary Percentage of participants with comorbidities Percentage of participants with comorbidities will be collected:
Depression
Anxiety
Hypertension
Hypercholesterolemia
Chronic lung disease
Diabetes
Autoimmune disease
Migraine
Cancer (solid/blood)
Neurological Disease
Cardiovascular Disease
Other
Baseline
Primary Percentage of participants by number of comorbidities Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected Baseline
Primary Percentage of smoking participants Percentage of smoking participants will be collected Baseline
Primary Percentage of alcohol intake participants Percentage of alcohol intake participants will be collected Baseline
Primary Percentage of patients by employment status Percentage of patients by employment status (yes/no) will be collected Baseline
Primary Percentage of participants by monthly income Percentage of participants by monthly income (< 500$, 500-1000$, 1000-5000$, > 5000$) will be collected Baseline
Primary Percentage of participants by educational level Percentage of participants by educational level (college level, university level, none, other) will be collected Baseline
Primary Percentage of participants by ethnicity Percentage of participants by ethnicity will be collected:
Nationals
Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other
Baseline
Primary Percentage of patients by frequency preference Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected Baseline
Primary Percentage of patients by route of administration Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected Baseline
Primary Percentage of participants by type of coverage Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected Baseline
Secondary Treatment Satisfaction Questionnaire for Medicines (TSQM) TSQM, 1.4 Version (1.4) in English and Arabic will be used covering four areas of treatment-related satisfaction, which are safety, convenience, overall satisfaction, and effectiveness. The domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain baseline, 6 months, and 12 months
Secondary Total number of visits Total number of visits will be collected 12 months
Secondary Number of visits to clinics Number of visits to clinics will be collected 12 months
Secondary Reason for out patient department (OPD) visit Reason for OPD visit will be collected 12 months
Secondary Number and reason of ER visits Number and reason of Emergency Room (ER) visits will be collected 12 months
Secondary Number and reason of hospitalizations Number and reason of hospitalizations will be collected 12 months
Secondary Length of hospital stay Length of hospital stay (in days) will be collected 12 months
Secondary proxy costs for each visit proxy costs for each visit by type and for all visits will be collected 12 months
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