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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT03562975
• Date of registration: 23/05/2018
• Prospective Registration: Yes
• Primary sponsor: University of South Florida
• Public title: Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
• Scientific title: A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™
• Date of first enrolment: July 23, 2018
• Target sample size: 18
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03562975
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Janice Y Maldonado, MD
• Affiliation: University of South Florida

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Nervous System Diseases

Demyelinating Diseases

Pathologic Processes

Relapsing Remitting Multiple Sclerosis

Autoimmune Diseases

Primary Progressive Multiple Sclerosis

Immune System Diseases

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

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]

Secondary Outcome(s)

The Upper Extremity Functional Index (UEFI) [Time Frame: 24 months]

9-Hole Peg Test [Time Frame: 24 months]

Secondary ID(s)

OCRE-UP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.