Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: ofatumumab for Relapsing Multiple Sclerosis

This is an watch-and-measure (no experimental treatment required), non-treatment, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years.

Official registry: https://clinicaltrials.gov/study/NCT05344469 · Novartis Pharmaceuticals · enrollment listed as 800

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 800 people at 109 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

Interventions: ofatumumab, glatiramer acetate, interferon β1, teriflunomide, dimethyl fumarate (DMF), diroximel fumarate (DRF)

Primary outcome (registry wording): Proportion of patients who continue to receive their baseline treatment

Who it is for (from inclusion criteria)

  • Ages 18 Years to 100 Years
  • Male or female patients aged ≥18 years at enrollment
  • Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
  • RMS with active disease as defined by Lublin et al. (2014)
  • Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
  • Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
  • Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment
  • Cohort 2 who can join:

Public study contact (from the registry)

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

109 listed

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NCT00794352 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

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NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital

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Phase 3: testing Best Available Therapy (BAT) for Relapsing Multiple Sclerosis

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FAQ about this NCT record

Is NCT05344469 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05344469?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05344469?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary