drugset / Trial / NCT05285891
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Phase 4
Recruiting
123 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence · collabGenentech, Inc. · collabRho Federal Systems Division, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2023-01-12
- Primary completion
- 2030-05-01
- Completion
- 2030-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocrelizumab | Monoclonal antibody | 600 mg | Intravenous |