Multiple Sclerosis Trial, Recruiting NCT05344469 Sponsor: Novartis Pharmaceuticals Condition: Multiple Sclerosis
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Multiple Sclerosis Trial, Recruiting

NCT05344469
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For Cohort 1:

  • People aged 18 or older who have agreed to participate by signing a consent form
  • People diagnosed with multiple sclerosis (MS) according to a specific set of recognised diagnostic guidelines (the 2017 McDonald criteria)
  • People with a relapsing form of MS that is considered "active" based on defined medical standards
  • People who have had no more than 1 relapse in the past year and no more than 2 relapses in the past two years
  • People with a low level of disability, measured by a standard MS scoring tool (EDSS score between 0 and 2.5)
  • People who are about to start, or have started within the last 14 days, an approved injectable MS disease-modifying treatment (DMT) as part of their regular medical care

For Cohort 2:

  • People aged 18 or older who have agreed to participate by signing a consent form
  • People diagnosed with MS according to updated 2024 diagnostic guidelines
  • People with a relapsing form of MS that is considered "active" based on defined medical standards
  • People who have had no more than 1 relapse in the past year and no more than 2 relapses in the past two years
  • People with a low level of disability (EDSS score between 0 and 3.0)
  • People who are about to start, or have started within the last 14 days, an approved injectable or oral MS disease-modifying treatment, with specific treatment history requirements depending on which medication is being used (confirm with trial site)

Who may not be able to join:

For Cohort 1:

  • People being treated with a medication in a way that falls outside its approved use
  • People whose first MS symptoms appeared more than 5 years ago
  • People who have previously used any MS disease-modifying treatment, unless that treatment was an approved injectable DMT started within the last 14 days
  • People whose most recent relapse before joining caused severe ongoing difficulties in daily life, as determined by the treating doctor
  • People who recovered poorly from their first two MS relapses, as determined by the treating doctor
  • People with a specific level of muscle weakness or movement difficulty measured by a standard MS assessment tool (Pyramidal Functions score of 2 or higher)
  • People currently participating in another clinical trial or another Novartis-sponsored observational study involving ofatumumab

For Cohort 2:

  • People being treated with a medication in a way that falls outside its approved use
  • People whose first MS symptoms appeared more than 5 years ago
  • People currently participating in another clinical trial or another Novartis-sponsored observational study involving ofatumumab
  • People who were previously enrolled in Cohort 1 of this trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: +41613241111

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
10 May 2022
Est. completion
30 May 2029

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Proportion of patients who continue to receive their baseline treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov