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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The investigators are measuring the effectiveness of Ocrevusâ„¢ in helping patients with hand or arm weakness, especially if posed by a more advanced MS patient than those included in the clinical trials.
Ocrevusâ„¢ 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 Ocrevusâ„¢ 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 Ocrevusâ„¢ (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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and hence is an immunosuppressive drug candidate. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 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). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stabilization of the Upper Extremity Functional Index (UEFI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen in a clinical setting for the treatment of Multiple Sclerosis who are interested in starting Ocrevus but who are currently not on Ocrevus
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| Name | Affiliation | Role |
|---|---|---|
| Janice Y Maldonado, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carol and Frank Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24664300 | Background | Lamers I, Feys P. Assessing upper limb function in multiple sclerosis. Mult Scler. 2014 Jun;20(7):775-84. doi: 10.1177/1352458514525677. Epub 2014 Mar 24. | |
| 6685237 | Background | Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444. |
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Enrollment occured July 2018 through September 2020 at a university medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | <20% Change of Clinical Stabalization From Baseline | This arm included patients who experienced <20% change in upper extremity function from baseline to 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2020 |
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| 24 months |
| Stabilization of 9-Hole Peg Test Scores | 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. | 24 months |
| 25772899 | Background | Ontaneda D, Fox RJ, Chataway J. Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives. Lancet Neurol. 2015 Feb;14(2):208-23. doi: 10.1016/S1474-4422(14)70264-9. |
| 11971105 | Background | Schwid SR, Goodman AD, McDermott MP, Bever CF, Cook SD. Quantitative functional measures in MS: what is a reliable change? Neurology. 2002 Apr 23;58(8):1294-6. doi: 10.1212/wnl.58.8.1294. |
| 18796752 | Background | Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9. doi: 10.2519/jospt.1992.16.5.215. |
| 21486517 | Background | Benedict RH, Holtzer R, Motl RW, Foley FW, Kaur S, Hojnacki D, Weinstock-Guttman B. Upper and lower extremity motor function and cognitive impairment in multiple sclerosis. J Int Neuropsychol Soc. 2011 Jul;17(4):643-53. doi: 10.1017/S1355617711000403. |
| Background | Stratford P, Binkley J, Stratford D. Development and initial validation of the upper extremity functional index. Physiotherapy Canada 2001;53(4):259-67. |
| Background | Ropper AH, Samuels M.A. Principals of Neurology. 9th edition. New York: McGraw-Hill, 2009. |
| Background | Genentech. Ocrevusâ„¢: Highlights of prescribing information. 2017. |
| Background | Goodin DS. Multiple Sclerosis and Related Disorders. Amsterdam, The Netherlands: Elsevier, 2014. |
| Background | Fox, EJ, Markowitz, C, Montalban, X, et al. Effect of Ocrelizumab on Upper Extremity Function in Patients With Primary Progressive Multiple Sclerosis in the ORATORIO Study. Presented at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Meeting; 25-28 October 2017; Paris, France. |
| 28002688 | Result | Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21. |
| 28002679 | Result | Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21. |
| 11405811 | Result | Cohen JA, Cutter GR, Fischer JS, Goodman AD, Heidenreich FR, Jak AJ, Kniker JE, Kooijmans MF, Lull JM, Sandrock AW, Simon JH, Simonian NA, Whitaker JN. Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial. Arch Neurol. 2001 Jun;58(6):961-7. doi: 10.1001/archneur.58.6.961. |
| 24631802 | Result | Lamers I, Kelchtermans S, Baert I, Feys P. Upper limb assessment in multiple sclerosis: a systematic review of outcome measures and their psychometric properties. Arch Phys Med Rehabil. 2014 Jun;95(6):1184-200. doi: 10.1016/j.apmr.2014.02.023. Epub 2014 Mar 13. |
| 11911515 | Result | Feys P, Duportail M, Kos D, Van Asch P, Ketelaer P. Validity of the TEMPA for the measurement of upper limb function in multiple sclerosis. Clin Rehabil. 2002 Mar;16(2):166-73. doi: 10.1191/0269215502cr471oa. |
| 21261965 | Result | Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5. |
| 25125777 | Result | Chesworth BM, Hamilton CB, Walton DM, Benoit M, Blake TA, Bredy H, Burns C, Chan L, Frey E, Gillies G, Gravelle T, Ho R, Holmes R, Lavallee RL, MacKinnon M, Merchant AJ, Sherman T, Spears K, Yardley D. Reliability and validity of two versions of the upper extremity functional index. Physiother Can. 2014 Summer;66(3):243-53. doi: 10.3138/ptc.2013-45. |
| 16678208 | Result | Yozbatiran N, Baskurt F, Baskurt Z, Ozakbas S, Idiman E. Motor assessment of upper extremity function and its relation with fatigue, cognitive function and quality of life in multiple sclerosis patients. J Neurol Sci. 2006 Jul 15;246(1-2):117-22. doi: 10.1016/j.jns.2006.02.018. Epub 2006 May 5. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinical Stabilization (Defined as no Significant Change (≤20%) From Baseline | Measure of upper extremity function over 24 months after initiation of Ocrevus™ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | 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). | 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. | Posted | Count of Participants | Participants | 24 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Stabilization of the Upper Extremity Functional Index (UEFI) | 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. | Posted | Count of Participants | Participants | 24 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Stabilization of 9-Hole Peg Test Scores | 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. | Posted | Count of Participants | Participants | 24 months |
|
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | <20% Change of Clinical Stabalization From Baseline | This arm included patients who experienced <20% in upper extremity function from baseline to 24 months. | 1 | 18 | 3 | 18 | 17 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Sepsis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypoxic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Gradual Worsening of Trunk Strength | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Weakness of Right Hand | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased spasticity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Benign Prostatic Hyperplasia | Renal and urinary disorders | Systematic Assessment |
| ||
| Falls | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral Leg Edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Severe Fatigue | Endocrine disorders | Systematic Assessment |
| ||
| Fatigue | Endocrine disorders | Systematic Assessment |
| ||
| Increased Fatigue | Endocrine disorders | Systematic Assessment |
| ||
| Increased spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| right leg spasticity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Bilateral Spasticity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intermittent Spasticity Increased (Abdomen to Knees) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| right foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| mild pain due to fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intermittent Lower Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Right Side Mid Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Painful Urination | Renal and urinary disorders | Systematic Assessment |
| ||
| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lower Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Right Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Itchy and Painful Throat | General disorders | Systematic Assessment |
| ||
| Left Forearm Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral Ankle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bilateral Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intermittent Bilateral Calf Pain | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Intermittent Bilateral Arm Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Difficulty Moving Right Leg | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased weakness right side of body | Nervous system disorders | Systematic Assessment |
| ||
| MS Exacerbation Flare | Nervous system disorders | Systematic Assessment |
| ||
| Broken Rib | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Leg Swelling (L foot, ankle, leg from knee down) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Weakness | Nervous system disorders | Systematic Assessment |
| ||
| Lymphedema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Loose Cough | Infections and infestations | Systematic Assessment |
| ||
| Night Sweats | Infections and infestations | Systematic Assessment |
| ||
| Asthma Exacerbation | Infections and infestations | Systematic Assessment |
| ||
| Acute Hypoxic Respiratory Failure | Infections and infestations | Systematic Assessment |
| ||
| Face and Head Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Acute Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Worsening Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Urgency | Renal and urinary disorders | Systematic Assessment |
| ||
| Increased Left Left Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Intermittent Headaches | General disorders | Systematic Assessment |
| ||
| Dry Skin Bilateral Lower Legs | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Decreased Balance | Nervous system disorders | Systematic Assessment |
| ||
| Intermittent Itchiness of the Face | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Left Leg Burning Sensation | Nervous system disorders | Systematic Assessment |
| ||
| Left Leg Spasms | Nervous system disorders | Systematic Assessment |
| ||
| Worsening Whole Body Spasms | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Increased Bilateral Hand Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Leg Weakness Bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hair loss | General disorders | Systematic Assessment |
| ||
| Increased Hair Loss | General disorders | Systematic Assessment |
| ||
| Increased Bilateral Foot Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Increased Bilateral Hand Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Bilateral Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
| ||
| Increased Foot Drop | Nervous system disorders | Systematic Assessment |
| ||
| Increased Right Foot Drop | Nervous system disorders | Systematic Assessment |
| ||
| Memory Decline | General disorders | Systematic Assessment |
| ||
| High Blood sugar | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cellulitis Foot | Infections and infestations | Systematic Assessment |
| ||
| Dry Skin Patches on Hands and Back | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Infusion Related Reaction Formication | Nervous system disorders | Systematic Assessment |
| ||
| Bilateral Small Red Blotches on Skin of Arms | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| viral Infection | Infections and infestations | Systematic Assessment |
| ||
| Increased Leg Weakness | Nervous system disorders | Systematic Assessment |
| ||
| Increased Generalized Weakness | Nervous system disorders | Systematic Assessment |
| ||
| Intermittent Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abnormal Kidney Function | Hepatobiliary disorders | Systematic Assessment |
| ||
| Increased Bilateral Leg Heaviness | General disorders | Systematic Assessment |
| ||
| Bilateral Leg Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left Arm Numbness | Nervous system disorders | Systematic Assessment |
| ||
| Tricuspid Regurgitation | Cardiac disorders | Systematic Assessment |
| ||
| Compound Melanocytic Nevus with Features of a Dysplastic Nevus of the Left Abdomen | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Worsening Essential Tremor Bilateral Hands | Nervous system disorders | Systematic Assessment |
| ||
| Floater Left Eye | Eye disorders | Systematic Assessment |
| ||
| Partial Detached Retina Left Eye | Eye disorders | Systematic Assessment |
| ||
| Chronic Low Blood Pressure | General disorders | Systematic Assessment |
| ||
| Worsening Arthritis Bilateral Hands | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sciatica Left Side | Nervous system disorders | Systematic Assessment |
| ||
| Infusion Related Reaction: Itchy Throat | General disorders | Systematic Assessment |
| ||
| Covid-19 vaccine | Surgical and medical procedures | Systematic Assessment |
| ||
| Worsening Bilateral Hand Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased Right Foot Drop | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Tooth pulled | General disorders | Systematic Assessment |
| ||
| Chronic Bilateral Leg Weakness | Nervous system disorders | Systematic Assessment |
| ||
| Left Knee Small Cyst Growth | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Low Iron | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| High Cholesterol | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus Drainage | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Intermittent Weakness | Nervous system disorders | Systematic Assessment |
| ||
| Chronic Deep Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Back Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Infusion Related Reaction: Chronic Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tingling of Interglutal Cleft | Nervous system disorders | Systematic Assessment |
| ||
| Numbness of Interglutal Cleft | Nervous system disorders | Systematic Assessment |
| ||
| Right Knee Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Left Eye Cataract Surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Mucosal Thickening Removal From Sinus Cavity | Surgical and medical procedures | Systematic Assessment |
| ||
| Right Shoulder Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Covid-19 infection | Infections and infestations | Systematic Assessment |
| ||
| Intermittent Migraines | General disorders | Systematic Assessment |
| ||
| Increased Right Arm Tremors | Nervous system disorders | Systematic Assessment |
| ||
| Increased Bilateral Hand Tremors | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | University Of South Florida | 18139749423 | amjackson@usf.edu |
| Jun 21, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D010335 | Pathologic Processes |
| D003711 | Demyelinating Diseases |
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
Not provided
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| >=65 years |
|
|
|