Autopsy report · NCT04878211

A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

“Trial was terminated for business reasons. There has been no change in the benefit/risk profile of ofatumumab.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 1 year 10 months before it stopped.
• 24 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Relapsing Multiple Sclerosis (RMS)

Interventions

Ofatumumab; mRNA COVID-19 vaccine; interferon or glatiramer acetate

Participants

24

Sites

7

Countries

United States

Trials that died the same way

• Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
  “The clinical development of intravenously administered ofatumumab in RA will no longer be pursued, so this study was prematurely terminated by the Sponsor.” (75% match in meaning)
• A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer
  “The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.” (73% match in meaning)
• Study of Inlexisertib (DCC-3116) in Participants With RAS/MAPK Pathway Mutant Solid Tumors
  “Trial terminated due to business decision, not based on any safety or efficacy concerns.” (71% match in meaning)
• Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
  “The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.” (70% match in meaning)
• A Study to Evaluate the Efficacy and Safety of REL-1017 As Adjunctive Treatment of Major Depressive Disorder (MDD)
  “The study was withdrawn based on business-related matters and there are no new safety concerns related to the trial. No patients were enrolled.” (69% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.