NCT03562975

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

Completed Results posted Last updated 10 December 2024

What this trial tests

trial testing Ocrelizumab in Multiple Sclerosis in 18 participants. Completed in 11 January 2023.

Timeline

23 July 2018

Primary endpoint
11 January 2023

11 January 2023

Quick facts

Lead sponsor	University of South Florida
Status	Completed
Study type	OBSERVATIONAL
Enrollment	18
Start date	23 July 2018
Primary completion	11 January 2023
Estimated completion	11 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Ocrelizumab (OCRELIZUMAB) — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Pathologic Processes — all drugs for Pathologic Processes →
• Demyelinating Diseases — all drugs for Demyelinating Diseases →
• Nervous System Diseases — all drugs for Nervous System Diseases →

Sponsor

University of South Florida

Who can join

Adults 18 to 70, any sex, with Multiple Sclerosis or Pathologic Processes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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" Primary · 24 months

The TEMPA is designed to assess the capabilities and limitations of upper limb function and 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. Each task is 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 (c

Group	Value	95% CI
<20% Change of Clinical Stabalization From Baseline	12

Stabilization of the Upper Extremity Functional Index (UEFI) Secondary · 24 months

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 in performing activities of daily living using the upper extremities including household and work activities, hobbies, lifting a bag of groceries, washing their scalp, pushing up on their hands, driving etc.

Group	Value	95% CI
Clinical Stabilization (Defined as no Significant Change (≤20%) From Baseline	9

Stabilization of 9-Hole Peg Test Scores Secondary · 24 months

The 9HPT is an objective measure of finger dexterity and upper extremity function, which is a widely used measure across most clinical trials in multiple sclerosis populations. The test involves the participant picking up and placing pegs one at time in the 9 holes and removing the pegs from their respective holes as quickly as possible. The participant completes the tasks twice on using their dominant hand, then twice on their non-dominant hand. Higher scores indicate a worse outcome.

Group	Value	95% CI
Clinical Stabilization (Defined as no Significant Change (≤20%) From Baseline	11

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

<20% Change of Clinical Stabalization From Baseline

Serious: 3/18 (17%)

Deaths: 1/18

Serious adverse events (7 terms)

Reaction	System	<20% Change of Clinical St…
Urinary Tract Infection	Infections and infestations	—
Fall	Injury, poisoning and procedural complications	—
Renal Failure	Renal and urinary disorders	—
Sepsis	Gastrointestinal disorders	—
Hypoxic Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—
Acute Pneumonia	Respiratory, thoracic and mediastinal disorders	—
Death	General disorders	—

Other adverse events (115 terms — click to expand)

Reaction	System	<20% Change of Clinical St…
Falls	Musculoskeletal and connective tissue disorders	—
Urinary Tract Infection	Infections and infestations	—
Increased Fatigue	Endocrine disorders	—
Intermittent Headaches	General disorders	—
Decreased Balance	Nervous system disorders	—
Increased spasticity	Musculoskeletal and connective tissue disorders	—
Lower Back Pain	Musculoskeletal and connective tissue disorders	—
Urinary Incontinence	Renal and urinary disorders	—
Increased Bilateral Foot Numbness	Nervous system disorders	—
Memory Decline	General disorders	—
High Blood sugar	Blood and lymphatic system disorders	—
Worsening Arthritis Bilateral Hands	Musculoskeletal and connective tissue disorders	—
Gradual Worsening of Trunk Strength	Musculoskeletal and connective tissue disorders	—
Increased Weakness of Right Hand	Musculoskeletal and connective tissue disorders	—
Benign Prostatic Hyperplasia	Renal and urinary disorders	—
Bilateral Leg Edema	Musculoskeletal and connective tissue disorders	—
Severe Fatigue	Endocrine disorders	—
Fatigue	Endocrine disorders	—
Increased spinal pain	Musculoskeletal and connective tissue disorders	—
Increased anxiety	Psychiatric disorders	—
Anxiety	Psychiatric disorders	—
right leg spasticity	Musculoskeletal and connective tissue disorders	—
Increased Bilateral Spasticity	Musculoskeletal and connective tissue disorders	—
Intermittent Spasticity Increased (Abdomen to Knees)	Musculoskeletal and connective tissue disorders	—
right foot pain	Musculoskeletal and connective tissue disorders	—
mild pain due to fall	Musculoskeletal and connective tissue disorders	—
Intermittent Lower Back Pain	Musculoskeletal and connective tissue disorders	—
Right Side Mid Back Pain	Musculoskeletal and connective tissue disorders	—
Painful Urination	Renal and urinary disorders	—
Groin Pain	Musculoskeletal and connective tissue disorders	—
Increased Right Knee Pain	Musculoskeletal and connective tissue disorders	—
Itchy and Painful Throat	General disorders	—
Left Forearm Pain	Musculoskeletal and connective tissue disorders	—
Bilateral Ankle Pain	Musculoskeletal and connective tissue disorders	—
Bilateral Knee Pain	Musculoskeletal and connective tissue disorders	—
Left Knee Pain	Musculoskeletal and connective tissue disorders	—
Intermittent Bilateral Calf Pain	Metabolism and nutrition disorders	—
Intermittent Bilateral Arm Pain	Musculoskeletal and connective tissue disorders	—
Increased Shortness of Breath	Respiratory, thoracic and mediastinal disorders	—
Difficulty Moving Right Leg	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Urinary Tract Infection, Fall, Renal Failure, Sepsis, Hypoxic Respiratory Failure, Acute Pneumonia, Death.

Data from ClinicalTrials.gov NCT03562975 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnosis and Management of Progressive Multiple Sclerosis.
   Macaron G, Ontaneda D. · · 2019 · cited 47× · PMID 31362384 · DOI 10.3390/biomedicines7030056
2. A Milestone in Multiple Sclerosis Therapy: Monoclonal Antibodies Against CD20-Yet Progress Continues.
   Frisch ES, Pretzsch R, Weber MS. · · 2021 · cited 22× · PMID 33880738 · DOI 10.1007/s13311-021-01048-z