N/A
N=18
Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
Multiple Sclerosis · Pathologic Processes · Demyelinating Diseases · Nervous System Diseases · Autoimmune Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03562975 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Oct 2024
Primary outcome: Primary: 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" — 12 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ocrelizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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" |
12 | — |
| SECONDARY Stabilization of the Upper Extremity Functional Index (UEFI) |
9 | — |
| SECONDARY Stabilization of 9-Hole Peg Test Scores |
11 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03562975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.