Phase 4 Multiple Sclerosis Trial, Recruiting NCT04650321 Sponsor: University of Colorado, Denver Condition: Multiple Sclerosis
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Phase 4 Multiple Sclerosis Trial, Recruiting

NCT04650321
Recruiting Phase 4

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:

  • People who are currently active patients at the Rocky Mountain MS Center (RMMSC) at the time of giving final study consent.
  • People who are between 18 and 55 years old at the time of giving final study consent.
  • People who have been diagnosed with primary progressive or relapsing multiple sclerosis (MS), as defined by a specific set of medical guidelines from 2017.
  • People who have already received at least their first 600 mg dose of the medication ocrelizumab.
  • People who are living in the Denver metro, Fort Collins, or Colorado Springs area at the time of giving final study consent.
  • People whose MS-related disability falls within a certain range on a patient-reported scale called the Patient Determined Disease Steps (PDDS), scoring between 0 and 6.5.
  • People who are able to complete written questionnaires that have been developed and validated in English.
  • People who are able and willing to give informed consent using an electronic signature, in line with local and FDA requirements.
  • People whose treating neurologist at RMMSC considers it medically appropriate to continue ocrelizumab treatment at the time of giving final study consent.

Who may not be able to join:

  • People who are pregnant, planning to become pregnant, or breastfeeding at the time of giving final study consent or on the day of the infusion.
  • People who have previously taken part in the SaROD trial at the RMMSC site.
  • People whose blood test results, processed by a University of Colorado Hospital laboratory, are considered by their treating neurologist at RMMSC to make a home infusion medically inappropriate (confirm with trial site for details on which specific results apply).

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 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Timothy L Vollmer, MD, University of Colorado, Denver

Phone: 303-724-2635

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
Phase 4
Registry
ClinicalTrials.gov
Start date
1 March 2021
Est. completion
31 August 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Severe infusion reactions; Infusion reactions

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: 28 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