Clinical Trials Directory

Trials / Completed

CompletedNCT03562975

Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus

A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™

Status
Completed
Phase
—
Study type
Observational
Enrollment
18 (actual)
Sponsor
University of South Florida · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The investigators are measuring the effectiveness of Ocrevus™ in helping patients with hand or arm weakness, especially if posed by a more advanced MS patient than those included in the clinical trials.

Detailed description

Ocrevus™ is the first FDA approved disease-modifying treatment for primary progressive multiple sclerosis (PPMS) as well as relapsing MS. In the clinical trials considered by the FDA (OPERA I/II, ORATORIO), the highest Expanded Disability Status Scale (EDSS) included in the participants was 5.5 (OPERA I/II) and 6.5 (ORATORIO). The EDSS score is heavily weighted on walking ability and is not a useful measurement for UE function. The primary endpoint in the primary progressive MS trial with Ocrevus™ was EDSS and in the relapsing MS studies, EDSS was used as a secondary endpoint. The Multiple Sclerosis Functional Composite (MSFC) score (Z score), a composite of quantitative measure of walking speed, upper limb coordinated movement (9 Hole Peg Test/9HPT) and cognitive function, was obtained as a secondary clinical measure with scores being favorably higher in patients treated with Ocrevus™ (OPERA I/II).The z score, however, is not very useful in delineating which of the three clinical functions was maintained or showed less progression given that three domains are included in the score. Data presented recently from the Oratorio trial analyzed the intention to treat population of PPMS patients and the subgroups of patients with upper extremity functional impairment using the 9HPT; results demonstrated reduction in risk of clinical progression in upper extremity disability in patients treated with Ocrevus compared to placebo. There was improvement in the change from baseline to week 120 in 9HPT time in treated patients. Abnormal baseline 9HPT was defined as \>25 seconds and upper extremities were defined as "better hand" and "worse hand", each individually tested, with clinical progression determined at 12 and 24 weeks in 3 sub-categories of progression: lengthened time of 9HPT \>15%, \>20% and 25%. In this study, investigators aim to not only replicate the results in the Oratorio trial with upper extremity dysfunction, but also widen the spectrum of patients that may benefit (given an expanded MS population of patients, not exclusive to PPMS and widen the It is anticipated that by using a test that better emulates activities of daily life performed with the upper extremity, such as the TEMPA (Test d'Evaluation de la performance des membres Superieurs e Personnes Agees ) more real life application of the benefits of receiving treatment with Ocrevus will be obtained, and it is anticipated that patients can maintain the function they have or potentially improve function.

Conditions

Interventions

TypeNameDescription
DRUGOcrelizumabOcrelizumab is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and hence is an immunosuppressive drug candidate. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds

Timeline

Start date
2018-07-23
Primary completion
2023-01-11
Completion
2023-01-11
First posted
2018-06-20
Last updated
2024-12-10
Results posted
2024-10-28

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03562975. Inclusion in this directory is not an endorsement.