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

NCT03562975 | Completed Results FDA Drug

• 1 other identifier: OCRE-UP
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Pathologic Processes; Demyelinating Diseases; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Primary Progressive Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Stabilization of Scores Using 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"

  The TEMPA is designed to assess the capabilities and limitations of upper limb function and 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. Each task is 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).

  24 months

Secondary Outcomes (2)

• Stabilization of the Upper Extremity Functional Index (UEFI)

  24 months

• Stabilization of 9-Hole Peg Test Scores

  24 months

Interventions

Ocrelizumab DRUG

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

Also known as: Ocrevus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of South Florida: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Carol and Frank Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Related Publications (19)

• Lamers I, Feys P. Assessing upper limb function in multiple sclerosis. Mult Scler. 2014 Jun;20(7):775-84. doi: 10.1177/1352458514525677. Epub 2014 Mar 24.

  PMID: 24664300 BACKGROUND

• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

  PMID: 6685237 BACKGROUND

• Ontaneda D, Fox RJ, Chataway J. Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives. Lancet Neurol. 2015 Feb;14(2):208-23. doi: 10.1016/S1474-4422(14)70264-9.

  PMID: 25772899 BACKGROUND

• Schwid SR, Goodman AD, McDermott MP, Bever CF, Cook SD. Quantitative functional measures in MS: what is a reliable change? Neurology. 2002 Apr 23;58(8):1294-6. doi: 10.1212/wnl.58.8.1294.

  PMID: 11971105 BACKGROUND

• Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215.

  PMID: 18796752 BACKGROUND

• Benedict RH, Holtzer R, Motl RW, Foley FW, Kaur S, Hojnacki D, Weinstock-Guttman B. Upper and lower extremity motor function and cognitive impairment in multiple sclerosis. J Int Neuropsychol Soc. 2011 Jul;17(4):643-53. doi: 10.1017/S1355617711000403.

  PMID: 21486517 BACKGROUND

• Stratford P, Binkley J, Stratford D. Development and initial validation of the upper extremity functional index. Physiotherapy Canada 2001;53(4):259-67.

  BACKGROUND

• Ropper AH, Samuels M.A. Principals of Neurology. 9th edition. New York: McGraw-Hill, 2009.

  BACKGROUND

• Genentech. Ocrevus™: Highlights of prescribing information. 2017.

  BACKGROUND

• Goodin DS. Multiple Sclerosis and Related Disorders. Amsterdam, The Netherlands: Elsevier, 2014.

  BACKGROUND

• 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.

  BACKGROUND

• Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

  PMID: 28002688 RESULT

• Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

  PMID: 28002679 RESULT

• Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Jak AJ, Kniker JE, Kooijmans MF, Lull JM, Sandrock AW, Simon JH, Simonian NA, Whitaker JN. Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial. Arch Neurol. 2001 Jun;58(6):961-7. doi: 10.1001/archneur.58.6.961.

  PMID: 11405811 RESULT

• Lamers I, Kelchtermans S, Baert I, Feys P. Upper limb assessment in multiple sclerosis: a systematic review of outcome measures and their psychometric properties. Arch Phys Med Rehabil. 2014 Jun;95(6):1184-200. doi: 10.1016/j.apmr.2014.02.023. Epub 2014 Mar 13.

  PMID: 24631802 RESULT

• Feys P, Duportail M, Kos D, Van Asch P, Ketelaer P. Validity of the TEMPA for the measurement of upper limb function in multiple sclerosis. Clin Rehabil. 2002 Mar;16(2):166-73. doi: 10.1191/0269215502cr471oa.

  PMID: 11911515 RESULT

• Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5.

  PMID: 21261965 RESULT

• Chesworth BM, Hamilton CB, Walton DM, Benoit M, Blake TA, Bredy H, Burns C, Chan L, Frey E, Gillies G, Gravelle T, Ho R, Holmes R, Lavallee RL, MacKinnon M, Merchant AJ, Sherman T, Spears K, Yardley D. Reliability and validity of two versions of the upper extremity functional index. Physiother Can. 2014 Summer;66(3):243-53. doi: 10.3138/ptc.2013-45.

  PMID: 25125777 RESULT

• Yozbatiran N, Baskurt F, Baskurt Z, Ozakbas S, Idiman E. Motor assessment of upper extremity function and its relation with fatigue, cognitive function and quality of life in multiple sclerosis patients. J Neurol Sci. 2006 Jul 15;246(1-2):117-22. doi: 10.1016/j.jns.2006.02.018. Epub 2006 May 5.

  PMID: 16678208 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Pathologic Processes; Demyelinating Diseases; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Results Point of Contact

• Title: Clinical Research Manager
• Organization: University Of South Florida

amjackson@usf.edu

18139749423

Study Officials

• Janice Y Maldonado, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 20, 2018
• Study Start: July 23, 2018
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: December 10, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)