A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Browse trials for

• Multiple Sclerosis, Relapsing-Remitting 618

Keywords

• pediatric Multiple Sclerosis
• pediatric MS
• children MS
• children Multiple Sclerosis
• pediatric ocrelizumab

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's enrollment of 188 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Study arms

• Experimental
  Ocrelizumab

  Participants will receive ocrelizumab, as IV infusion Q24W. The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15, and subsequent doses are given as single infusions of ocrelizumab Q24W. Participants will also receive a placebo of fingolimod administered as QD capsule.

  Drug: Ocrelizumab · Other: Fingolimod Placebo

• Active comparator
  Fingolimod

  Participants will receive fingolimod PO, QD as per the prescribing information provided with fingolimod. Participants will also receive a placebo of ocrelizumab administered as IV infusion on Days 1 and 15, and Q24W thereafter.

  Other: Ocrelizumab Placebo · Drug: Fingolimod

Interventions

• DrugOcrelizumab

  Ocrelizumab, 300 milligrams (mg) will be administered as IV infusion to participants who weigh \< 35 kilograms (kg), and ocrelizumab 600 mg, IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart), and Q24W thereafter.

  Also known as: RO4964913; Ocrevus

• OtherOcrelizumab Placebo

  Ocrelizumab matching placebo will be administered as IV infusion on Day 1 and Day 15, and Q24W thereafter.

• DrugFingolimod

  Fingolimod will be administered QD as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).

  Also known as: Gilenya®

• OtherFingolimod Placebo

  Fingolimod matching placebo will be administered QD as a capsule.

Primary outcomes

1. Protocol-defined Annualized Relapse Rate (ARR)

   The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for \>24 hours \& should not be attributable to confounding clinical factors. The new/worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the expanded disability status scale (EDSS) score, or 2 points on one of the appropriate functional system (FS) scores, or 1 point on two or more of the appropriate FS scores. The change must affect the selected FS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Adjusted values were reported. OM assessed non inferiority of ocrelizumab vs fingolimod.

   Time frame: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

Secondary outcomes

1. Protocol-defined ARR

   The population-level summary is rate ratio of ARR. The ARR is calculated as the total number of protocol-defined relapses divided by the total patient-years. Protocol-defined relapse is the occurrence of new/worsening neurological symptoms attributable to multiple sclerosis (MS) and immediately preceded by relatively stable or improving neurological state for ≥ 30 days. Symptoms must persist for \>24 hours \& should not be attributable to confounding clinical factors. The new/worsening neurological symptoms must be accompanied by objective neurological worsening consistent with an increase of at least half a step on the expanded disability status scale (EDSS) score, or 2 points on one of the appropriate functional system (FS) scores, or 1 point on two or more of the appropriate FS scores. The change must affect the selected FS (i.e., pyramidal, ambulation, cerebellar, brainstem, sensory, or visual). Adjusted values were reported. OM assessed non superiority of ocrelizumab vs fingolimod.

   Time frame: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

2. Number of New or Enlarging T2-hyperintense Lesions (T2 Lesions), as Detected by Brain Magnetic Resonance Imaging (MRI)

   Number of new or enlarging T2 lesions for each participant was calculated as the sum of the individual number of new or enlarging T2 lesions as detected by brain MRI.

   Time frame: Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks)

3. Number of T1 Gd Lesions at Week 12

   Brain MRI with and without a Gd-contrast agent were performed to assess the number of Gd lesions.

   Time frame: At Week 12

4. Number of Participants With Adverse Events (AEs)

   An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

   Time frame: Up to approximately 7 years

5. Maximum Serum Concentration (Cmax) of Ocrelizumab

   Time frame: Cycle (1 Cycle=24 weeks)

6. Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC Tau) of Ocrelizumab

   Time frame: Cycle 1 (1 Cycle=24 weeks)

7. Number of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab

   Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to atezolizumab was determined by summing the ADA-positive participants across all timepoints.

   Time frame: Up to approximately 7 years

8. Levels of Cluster of Differentiation 19 (CD19) + B-cell Count in Blood

   CD19+ B-cell count in blood will be assessed using flow cytometry.

   Time frame: Up to approximately 7 years

Baseline characteristics

Publications

• Mar S, Valeriani M, Steinborn B, Schreiner T, Waubant E, Filippi M, Kotulska K, Mazurkiewicz-Beldzinska M, El Azzouzi B, Lin CJ, Shen YA, Kletzl H, Evershed J, Hogea A, Manlius C, Bonati U, Banwell B. Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study. J Neurol. 2025 Jan 15;272(2):137. doi: 10.1007/s00415-024-12879-z. PubMed 39812825 ↗

Study documents

• Study protocol ↗ · Mar 23, 2026
• Statistical analysis plan ↗ · Feb 20, 2025

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing