Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
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|ClinicalTrials.gov Identifier: NCT03562975|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : October 28, 2019
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis Pathologic Processes Demyelinating Diseases Nervous System Diseases Autoimmune Diseases Immune System Diseases Primary Progressive Multiple Sclerosis Relapsing Remitting Multiple Sclerosis||Drug: Ocrelizumab|
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.
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™|
|Actual Study Start Date :||July 23, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
- Drug: Ocrelizumab
Ocrelizumab 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 bindsOther Name: Ocrevus
- The Test d'Evaluation de la performance des Membres Supérieurs des Personnes Agées (TEMPA) -Translasted in English to mean "Performance Evaluation Test for the Elderly" [ Time Frame: 24 months ]The TEMPA consists of 9 tasks that mimic tasks of daily living that include picking up a jar, taking a spoonful of coffee from a jar, pouring water from a pitcher, handling coins, writing on an envelope and opening a pill container, tying a scarf around one's neck, shuffle and deal playing cards, and picking up and moving small objects. The tasks are assessed by a rater by measuring speed of execution (seconds) and by functional rating of the subject's independence in performing them using an ordinal scale of 0 (completed without difficulty) to -3 (could not complete the task).
- The Upper Extremity Functional Index (UEFI) [ Time Frame: 24 months ]The Upper Extremity Functional Index (UEFI) is a self-administered questionnaire which measures disability in patients with upper extremity conditions on a 5-point Likert scale. Scores range from 0 to 60 with lower scores indicating more functional difficulty.
- 9-Hole Peg Test [ Time Frame: 24 months ]The 9HPT is an objective measure of manual dexterity, which is incorporated into the MSFC, is a widely used measure across most clinical trials in multiple sclerosis populations.
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): NCT03562975
|Contact: Amber K McPherson, BAemail@example.com|
|Contact: Angela M Aungst, MPHfirstname.lastname@example.org|
|United States, Florida|
|Carol and Frank Morsani Center for Advanced Healthcare||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Amber K McPherson, BA 813-974-9423 email@example.com|
|Contact: Angela M Aungst, MPH 813-974-6378 firstname.lastname@example.org|
|Principal Investigator: Janice Y Maldonado, MD|
|Sub-Investigator: Derrick S Robertson, MD|
|Principal Investigator:||Janice Y Maldonado, MD||University of South Florida|