Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease. (CELLO)
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|ClinicalTrials.gov Identifier: NCT04877457|
Recruitment Status : Terminated (Slow enrollment)
First Posted : May 7, 2021
Last Update Posted : July 12, 2023
|Condition or disease||Intervention/treatment||Phase|
|Radiologically Isolated Syndrome Multiple Sclerosis||Drug: Ocrelizumab Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Randomization and blinding will be employed to minimize bias in treatment assignment and to provide the basis for valid statistical inference.|
|Official Title:||A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated Syndrome|
|Actual Study Start Date :||February 15, 2022|
|Actual Primary Completion Date :||June 12, 2023|
|Actual Study Completion Date :||June 12, 2023|
Three courses of ocrelizumab will be administered over the course of the study.
The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
Placebo Comparator: Placebo
Three courses of placebo will be administered over the course of the study.
Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
- Time to development of first new radiologic or clinical evidence of MS [ Time Frame: Up 4 years ]The primary efficacy endpoint for this study is to evaluate the efficacy of ocrelizumab compared with placebo on delaying the time to development of new radiological or clinical evidence of MS, defined as the time from baseline to first new T1 gadolinium-enhancing lesions and/or new or enlarging T2 lesions consistent with MS OR first clinical evidence of MS, i.e., neurological event resulting from CNS demyelination as evidenced by acute or progressive clinical syndrome consistent with MS.
- Cumulative number of new or enlarging T2 lesions [ Time Frame: Up to 4 years ]MRI scans will be used to determine the number of new or enlarging T2 lesions
- Change in T2-lesion volume [ Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks ]MRI scans will be used to the change in T2 lesions
- Cumulative number of new T1 gadolinium-enhancing lesions [ Time Frame: Up to 4 years ]MRI scans will be used to determine the cumulative number of new T1 gadolinium-enhancing lesions
- Change in total brain volume [ Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks ]MRI scan will be used to determine the change in total brain volume
- Change in total spinal cord volume [ Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 156 weeks, 208 weeks ]MRI scan will be used to determine the change in total brain volume
- Change in serum NfL (sNfL) [ Time Frame: Baseline, 24 weeks, 48 weeks, 72 weeks, 104 weeks, 130 weeks, 156 weeks, 182 weeks, 208 weeks ]Change in serum Nfl will be used measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877457
|United States, Connecticut|
|North Haven, Connecticut, United States, 06473|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, Ohio|
|Cleveland Clinic Melen Center|
|Cleveland, Ohio, United States, 44195|
|United States, Oklahoma|
|Oklahoma Medical Research Foundation|
|Oklahoma City, Oklahoma, United States, 73104|