Multiple Sclerosis Clinical Trial
Official title:
A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™
Verified date | November 2022 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | December 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Carol and Frank Morsani Center for Advanced Healthcare | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Genentech, Inc. |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 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). | 24 months | |
Secondary | The Upper Extremity Functional Index (UEFI) | 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. | 24 months | |
Secondary | 9-Hole Peg Test | 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. | 24 months |
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