Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis (NCT05285891)
Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)
🩺 Plain-English Summary (8th-Grade Level)
This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.
Who can join: Review the eligibility criteria below.
Location: Yale School of Medicine — New Haven, Connecticut
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Yale School of Medicine — New Haven, Connecticut
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Northwestern University — Chicago, Illinois
- Massachusetts General Hospital — Boston, Massachusetts
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts
- RWJ Barnabas Health — Livingston, New Jersey
- Icahn School of Medicine at Mount Sinai — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
- University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania
- University of Texas Southwestern Medical Center — Dallas, Texas
- The University of Texas Health Science Center at Houston, McGovern Medical School — Houston, Texas
- Virginia Commonwealth University School of Medicine — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: (215) 316-5151
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.