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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562975
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of South Florida

Brief 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.

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

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab


Intervention Details:
  • 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 binds
    Other Name: Ocrevus


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in a clinical setting for the treatment of Multiple Sclerosis who are interested in starting Ocrevus but who are currently not on Ocrevus
Criteria

Inclusion Criteria:

  • Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI])
  • Aged 18-70 at the time of informed consent
  • Must have a relapsing or progressive form of MS
  • Plan to begin Ocrevus™ treatment but have not actually had first treatment yet
  • Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment
  • EDSS 4.0-8.0
  • UE weakness in at least one limb, defined as grade 4/5 in ≥ 2 muscles per limb
  • Muscle weakness must be primarily related to MS
  • Joint range of motion must be within functional limits
  • Patient must be able to perform 9HPT and TEMPA tests with at least one limb

Exclusion Criteria:

  • Prior treatment with Ocrevus™ (Cannot already be on Ocrevus prior to joining the study)
  • Severe weakness in bilateral upper limbs causing complete loss of function
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity
  • Female subjects considering becoming pregnant while in the study
  • Female subjects who are currently pregnant or breast-feeding
  • Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.
  • Active Hepatitis B virus infections
  • Severe tremor/ataxia of the UE as defined by an EDSS with Cerebellar Functional System score of 3 or more due to upper extremity score (moderate tremor or clumsy movements interfere with function in all spheres)

Information from the National Library of Medicine

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


Contacts
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Contact: Amber K McPherson, BA 813-974-9423 amjackson@usf.edu
Contact: Angela M Aungst, MPH 813-974-6378 aaungst@usf.edu

Locations
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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    amjackson@usf.edu   
Contact: Angela M Aungst, MPH    813-974-6378    aaungst@usf.edu   
Principal Investigator: Janice Y Maldonado, MD         
Sub-Investigator: Derrick S Robertson, MD         
Sponsors and Collaborators
University of South Florida
Genentech, Inc.
Investigators
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Principal Investigator: Janice Y Maldonado, MD University of South Florida
Publications of Results:

Other Publications:
Stratford P, Binkley J, Stratford D. Development and initial validation of the upper extremity functional index. Physiotherapy Canada 2001;53(4):259-67.
Ropper AH, Samuels M.A. Principals of Neurology. 9th edition. New York: McGraw-Hill, 2009.
Genentech. Ocrevus™: Highlights of prescribing information. 2017.
Goodin DS. Multiple Sclerosis and Related Disorders. Amsterdam, The Netherlands: Elsevier, 2014.
Fox, EJ, Markowitz, C, Montalban, X, et al. Effect of Ocrelizumab on Upper Extremity Function in Patients With Primary Progressive Multiple Sclerosis in the ORATORIO Study. Presented at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting; 25-28 October 2017; Paris, France.

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03562975    
Other Study ID Numbers: OCRE-UP
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Nervous System Diseases
Multiple Sclerosis, Chronic Progressive
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs