Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocr… (NCT03562975) | Clinical Trial Compass
CompletedNot Applicable
Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
United States18 participantsStarted 2018-07-23
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 socia…