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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Study Purpose

This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

To participate in the study, all the following inclusion criteria must be met:
  • - Patients aged 18 years or older.
  • - Written informed consent obtained before participating in the study.
  • - Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
  • - Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
  • - Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).
  • - Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.

Exclusion Criteria:

To participate in the study, none of the following exclusion criteria must be met:
  • - Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  • - Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05809986
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Novartis Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Novartis Pharmaceuticals
Principal Investigator Affiliation Novartis Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Portugal
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsing Multiple Sclerosis
Additional Details

This is a 2 cohort, multi-center, observational study carried out in Portugal that aims to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and later in their disease (cohorts 1 and 2, respectively). Data will be collected during 3 visits distributed over a maximum period of 24 months. Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation. The study includes patients that have initiated Ofatumumab up to 12 months prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion. Patients in both cohorts will have to be treated with Ofatumumab for at least two years to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.

Arms & Interventions

Arms

: Cohort 1: Early treatment arm

All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch).

: Cohort 2: Late treatment arm

All patients who initiated Ofatumumab with more than 3 years of MS diagnosis.

Interventions

Other: - Ofatumumab

There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Novartis Investigative Site, Lisboa, Portugal

Status

Recruiting

Address

Novartis Investigative Site

Lisboa, , 1349-019

Site Contact

[email protected]

+41613241111

Nearest Location

Site Contact

[email protected]

+41613241111


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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