Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Neurology, Neurology, Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/6/2019 |
| Start Date: | July 23, 2018 |
| End Date: | August 2020 |
| Contact: | Amber K McPherson, BA |
| Email: | amjackson@health.usf.edu |
| Phone: | 813-974-9423 |
A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™
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.
or arm weakness, especially if posed by a more advanced MS patient than those included in the
clinical trials.
Ocrevus™ is the first FDA approved disease-modifying treatment for primary progressive
multiple sclerosis (PPMS) as well as relapsing MS. In the clinical trials considered by the
FDA (OPERA I/II, ORATORIO), the highest Expanded Disability Status Scale (EDSS) included in
the participants was 5.5 (OPERA I/II) and 6.5 (ORATORIO). The EDSS score is heavily weighted
on walking ability and is not a useful measurement for UE function. The primary endpoint in
the primary progressive MS trial with Ocrevus™ was EDSS and in the relapsing MS studies, EDSS
was used as a secondary endpoint. The Multiple Sclerosis Functional Composite (MSFC) score (Z
score), a composite of quantitative measure of walking speed, upper limb coordinated movement
(9 Hole Peg Test/9HPT) and cognitive function, was obtained as a secondary clinical measure
with scores being favorably higher in patients treated with Ocrevus™ (OPERA I/II).The z
score, however, is not very useful in delineating which of the three clinical functions was
maintained or showed less progression given that three domains are included in the score.
Data presented recently from the Oratorio trial analyzed the intention to treat population of
PPMS patients and the subgroups of patients with upper extremity functional impairment using
the 9HPT; results demonstrated reduction in risk of clinical progression in upper extremity
disability in patients treated with Ocrevus compared to placebo. There was improvement in the
change from baseline to week 120 in 9HPT time in treated patients. Abnormal baseline 9HPT was
defined as >25 seconds and upper extremities were defined as "better hand" and "worse hand",
each individually tested, with clinical progression determined at 12 and 24 weeks in 3
sub-categories of progression: lengthened time of 9HPT >15%, >20% and 25%.
In this study, investigators aim to not only replicate the results in the Oratorio trial with
upper extremity dysfunction, but also widen the spectrum of patients that may benefit (given
an expanded MS population of patients, not exclusive to PPMS and widen the It is anticipated
that by using a test that better emulates activities of daily life performed with the upper
extremity, such as the TEMPA (Test d'Evaluation de la performance des membres Superieurs e
Personnes Agees ) more real life application of the benefits of receiving treatment with
Ocrevus will be obtained, and it is anticipated that patients can maintain the function they
have or potentially improve function.
multiple sclerosis (PPMS) as well as relapsing MS. In the clinical trials considered by the
FDA (OPERA I/II, ORATORIO), the highest Expanded Disability Status Scale (EDSS) included in
the participants was 5.5 (OPERA I/II) and 6.5 (ORATORIO). The EDSS score is heavily weighted
on walking ability and is not a useful measurement for UE function. The primary endpoint in
the primary progressive MS trial with Ocrevus™ was EDSS and in the relapsing MS studies, EDSS
was used as a secondary endpoint. The Multiple Sclerosis Functional Composite (MSFC) score (Z
score), a composite of quantitative measure of walking speed, upper limb coordinated movement
(9 Hole Peg Test/9HPT) and cognitive function, was obtained as a secondary clinical measure
with scores being favorably higher in patients treated with Ocrevus™ (OPERA I/II).The z
score, however, is not very useful in delineating which of the three clinical functions was
maintained or showed less progression given that three domains are included in the score.
Data presented recently from the Oratorio trial analyzed the intention to treat population of
PPMS patients and the subgroups of patients with upper extremity functional impairment using
the 9HPT; results demonstrated reduction in risk of clinical progression in upper extremity
disability in patients treated with Ocrevus compared to placebo. There was improvement in the
change from baseline to week 120 in 9HPT time in treated patients. Abnormal baseline 9HPT was
defined as >25 seconds and upper extremities were defined as "better hand" and "worse hand",
each individually tested, with clinical progression determined at 12 and 24 weeks in 3
sub-categories of progression: lengthened time of 9HPT >15%, >20% and 25%.
In this study, investigators aim to not only replicate the results in the Oratorio trial with
upper extremity dysfunction, but also widen the spectrum of patients that may benefit (given
an expanded MS population of patients, not exclusive to PPMS and widen the It is anticipated
that by using a test that better emulates activities of daily life performed with the upper
extremity, such as the TEMPA (Test d'Evaluation de la performance des membres Superieurs e
Personnes Agees ) more real life application of the benefits of receiving treatment with
Ocrevus will be obtained, and it is anticipated that patients can maintain the function they
have or potentially improve function.
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:
- 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
- Prior treatment with Ocrevus™
- 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)
We found this trial at
1
site
Tampa, Florida 33617
Principal Investigator: Janice Y Maldonado, MD
Phone: 813-974-9423
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