Trial Outcomes & Findings for Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus (NCT NCT03562975)
NCT ID: NCT03562975
Last Updated: 2024-12-10
Results Overview
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 (completed without difficulty) to -3 (could not complete the task).
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
24 months
Results posted on
2024-12-10
Participant Flow
Enrollment occured July 2018 through September 2020 at a university medical clinic.
Participant milestones
| Measure |
<20% Change of Clinical Stabalization From Baseline
This arm included patients who experienced \<20% change in upper extremity function from baseline to 24 months.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
<20% Change of Clinical Stabalization From Baseline
This arm included patients who experienced \<20% change in upper extremity function from baseline to 24 months.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clinical Stabilization (Defined as no Significant Change (≤20%) From Baseline
n=18 Participants
Measure of upper extremity function over 24 months after initiation of Ocrevus™
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=18 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: cohort of patients with Multiple Sclerosis from University of South Florida Multiple Sclerosis Center. Individuals, ages 18-70, with relapsing or progressive forms of MS and UE impairment that satisfied the approved indication for ocrelizumab and received ocrelizumab treatment commercially were assessed quarterly and semi-annually over 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 (completed without difficulty) to -3 (could not complete the task).
Outcome measures
| Measure |
<20% Change of Clinical Stabalization From Baseline
n=15 Participants
This arm included patients who experienced \<20% change in upper extremity function from baseline to 24 months.
|
|---|---|
|
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
|
SECONDARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
<20% Change of Clinical Stabalization From Baseline
n=14 Participants
This arm included patients who experienced \<20% change in upper extremity function from baseline to 24 months.
|
|---|---|
|
Stabilization of the Upper Extremity Functional Index (UEFI)
|
9 Participants
|
SECONDARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
<20% Change of Clinical Stabalization From Baseline
n=15 Participants
This arm included patients who experienced \<20% change in upper extremity function from baseline to 24 months.
|
|---|---|
|
Stabilization of 9-Hole Peg Test Scores
|
11 Participants
|
Adverse Events
<20% Change of Clinical Stabalization From Baseline
Serious events: 3 serious events
Other events: 17 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
<20% Change of Clinical Stabalization From Baseline
n=18 participants at risk
This arm included patients who experienced \<20% in upper extremity function from baseline to 24 months.
|
|---|---|
|
Infections and infestations
Urinary Tract Infection
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Sepsis
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic Respiratory Failure
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pneumonia
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Death
|
5.6%
1/18 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
<20% Change of Clinical Stabalization From Baseline
n=18 participants at risk
This arm included patients who experienced \<20% in upper extremity function from baseline to 24 months.
|
|---|---|
|
Infections and infestations
Urinary Tract Infection
|
27.8%
5/18 • Number of events 5 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Gradual Worsening of Trunk Strength
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Weakness of Right Hand
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased spasticity
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Benign Prostatic Hyperplasia
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Falls
|
38.9%
7/18 • Number of events 8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Edema
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Endocrine disorders
Severe Fatigue
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Endocrine disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Endocrine disorders
Increased Fatigue
|
16.7%
3/18 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased spinal pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Increased anxiety
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right leg spasticity
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Bilateral Spasticity
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intermittent Spasticity Increased (Abdomen to Knees)
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
right foot pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
mild pain due to fall
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intermittent Lower Back Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Right Side Mid Back Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Painful Urination
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Right Knee Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Itchy and Painful Throat
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Left Forearm Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Ankle Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Knee Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Left Knee Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Intermittent Bilateral Calf Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Intermittent Bilateral Arm Pain
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Increased Shortness of Breath
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Difficulty Moving Right Leg
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased weakness right side of body
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
MS Exacerbation Flare
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Broken Rib
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Leg Swelling (L foot, ankle, leg from knee down)
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Lymphedema
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Osteoporosis
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Loose Cough
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Night Sweats
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Asthma Exacerbation
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Acute Hypoxic Respiratory Failure
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Face and Head Numbness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Acute Bronchitis
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Worsening Urinary Incontinence
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary Urgency
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Left Left Numbness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Intermittent Headaches
|
16.7%
3/18 • Number of events 3 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin Bilateral Lower Legs
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Decreased Balance
|
16.7%
3/18 • Number of events 3 • 24 months
|
|
Skin and subcutaneous tissue disorders
Intermittent Itchiness of the Face
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Left Leg Burning Sensation
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Left Leg Spasms
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Worsening Whole Body Spasms
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Bilateral Hand Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Leg Weakness Bilateral
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Hair loss
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Increased Hair Loss
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Bilateral Foot Numbness
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Nervous system disorders
Increased Bilateral Hand Numbness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Carpal Tunnel Syndrome
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Upper Respiratory Infection
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Foot Drop
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Right Foot Drop
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Memory Decline
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
High Blood sugar
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Infections and infestations
Cellulitis Foot
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin Patches on Hands and Back
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Infusion Related Reaction Formication
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Bilateral Small Red Blotches on Skin of Arms
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
viral Infection
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Leg Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Generalized Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Intermittent Vomiting
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Abnormal Kidney Function
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Increased Bilateral Leg Heaviness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Stiffness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Left Arm Numbness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Cardiac disorders
Tricuspid Regurgitation
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Compound Melanocytic Nevus with Features of a Dysplastic Nevus of the Left Abdomen
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Worsening Essential Tremor Bilateral Hands
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Eye disorders
Floater Left Eye
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Eye disorders
Partial Detached Retina Left Eye
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Chronic Low Blood Pressure
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Worsening Arthritis Bilateral Hands
|
11.1%
2/18 • Number of events 2 • 24 months
|
|
Nervous system disorders
Sciatica Left Side
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Infusion Related Reaction: Itchy Throat
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Covid-19 vaccine
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Worsening Bilateral Hand Cramping
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Increased Right Foot Drop
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Tooth pulled
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Chronic Bilateral Leg Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Knee Small Cyst Growth
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Low Iron
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
High Cholesterol
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Sinus Drainage
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Intermittent Weakness
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Deep Cough
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Spasms
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Infusion Related Reaction: Chronic Coughing
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Tingling of Interglutal Cleft
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Numbness of Interglutal Cleft
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Right Knee Spasms
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Left Eye Cataract Surgery
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Mucosal Thickening Removal From Sinus Cavity
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Right Shoulder Arthritis
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Infections and infestations
Covid-19 infection
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
General disorders
Intermittent Migraines
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Right Arm Tremors
|
5.6%
1/18 • Number of events 1 • 24 months
|
|
Nervous system disorders
Increased Bilateral Hand Tremors
|
5.6%
1/18 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place