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Natalizumab

Natalizumab is a monoclonal antibody used to treat relapsing-remitting multiple sclerosis and Crohn's disease.
It works by blocking the interaction between α4-integrin and its ligands, preventing the migration of immune cells into the central nervous system and reducing inflammation.
Natalizumab has been shown to reduce the frequency of relapses and slow the progression of disability in patients with multiple sclerosis.
However, it carries a risk of potentially serious side effects, including progressive multifocal leukoencephalopathy, and requires careful monitoring.
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Most cited protocols related to «Natalizumab»

Anti-JCV antibody index data were collected from anti-JCV antibody–positive MS patients who did not develop PML from 3 natalizumab clinical studies, AFFIRM (n = 359),1 (link) STRATIFY-1 (n = 680),7 (link) and STRATIFY-2 (n = 1,483)6 ; the total number of samples was 5,834. Because PML is an uncommon adverse event in natalizumab-treated patients, PML patient samples were obtained from clinical studies and postmarketing sources (n = 71 as of September 2012); only pre-PML samples available >6 months prior to PML diagnosis were included (total number of samples = 316, collected at a median duration of 4 years prior to PML diagnosis). Patients enrolled in clinical studies provided informed consent for participation. For all other patients, data were collected through standard pharmacovigilance practices.
Publication 2014
Antibodies, Anti-Idiotypic Diagnosis Natalizumab Patients
Data for this study were extracted from the LifeLink™ Health Plan Claims Database, a national managed care database, for the years 2007 and 2008. This database contained claims for more than 70 million patients enrolled in more than 100 health plans. To be included in the study, patients had to meet the following criteria:
A patient who had a natalizumab claim was included only if all of their disease-modifying drug claims were billed by National Drug Code (ie, as a pharmacy benefit). The HCPCS criterion removed all patients who had any disease-modifying drug claim reimbursed as a medical benefit. Expected days supply is not typically reported for HCPCS coded claims, making calculation of adherence problematic. Two variables in the prescription claims database were used for calculation of medication adherence. The first was the date the prescription was dispensed and the second was days supply on the claim as entered by the pharmacist.
Publication 2013
Health Planning Managed Care Natalizumab Patients Pharmaceutical Preparations
We conducted a systematic review of immunomodulatory DMTs for MS. The PubMed search filter “clinical trial” and the key words “multiple sclerosis,” in combination with “interferon” (n = 842), “glatiramer acetate” (n = 192), “fingolimod” (n = 67), “dimethyl fumarate” (n = 18), “teriflunomide” (n = 15), “mitoxantrone” (n = 52), “daclizumab” (n = 29), “natalizumab” (n = 86), “alemtuzumab” (n = 23), “rituximab” (n = 15), “ocrelizumab” (n = 3), “laquinimod” (n = 10), and “siponimod” (n = 1) were used for screening relevant studies. In addition, we searched the public domain (including Clinicaltrials.gov) for non-PubMed sources with complete efficacy data on drugs currently under development. The inclusion criteria for selecting the trials were (1) randomized clinical trial in any MS subtype, (2) double-blinded or rater-blinded trial, (3) trial duration of at least a year (when counted in weeks, at least 48 weeks), (4) comparison between drug and placebo or between a drug and an active comparator (interferon beta), (5) the proportion of patients with confirmed disability progression (CDP; a change in EDSS confirmed in a subsequent follow-up visit after 3 or 6 months) measured in both groups as an outcome in the study, and (6) in trials with two arms, at least one arm of the trial used the FDA-approved dose of the drug (this arm was chosen for the analyses). The PRISMA flowchart (21 (link)) (Figure 1) provides details regarding the disposition of screened studies.
The following information was extracted from each study: author, trial name, year, drug, dose, control group (placebo or active comparator), MS subtype, sample sizes, trial duration, baseline patient characteristics, CDP in each group by the end of the trial, and p-values (Table 1, also see Supplementary Material for an Excel spreadsheet containing all trial data and accompanying calculations). For trials that did not list a hazard ratio, we calculated the percent inhibition of disability progression (%IDP) as follows:
%IDP=(1p^drugp^placebo)×100%
where p^drug represents the proportion of patients from the drug group with CDP, and p^placebo represents the proportion of patients from the comparator group with CDP by the end of the trial. This formula is equivalent to a relative risk reduction, where the ratio between p^drug and p^placebo represents the relative risk of disability progression.
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Publication 2017
Alemtuzumab Daclizumab Dimethyl Fumarate Disabled Persons Disease Progression Fingolimod Glatiramer Acetate Immunomodulation Interferon, beta Interferons laquinimod Mitoxantrone Multiple Sclerosis N,N-Dimethyltryptamine Natalizumab ocrelizumab Patients Pharmaceutical Preparations Placebos prisma Psychological Inhibition Public Domain Rituximab siponimod teriflunomide
To be included in the study individuals need to be diagnosed with either relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary-progressive MS (PPMS) according to the 2010 revised McDonald [19 (link) or previous established diagnostic criteria (McDonald or Poser) [20 (link), 21 (link)]. Patients diagnosed with a clinically isolated syndrome (CIS), radiologically isolated syndrome (RIS) or neuromyelitis optica (NMO) can also be included [22 (link), 23 (link)]. We aimed to build a cohort of patients that was homogeneous and informative for the questions we wanted to answer. Eligible criteria were: 1) absence of treatment with any MS specific DMD, or 2) need to either begin or switch to a different DMD as judged by the treating physician, or 3) initiation of a new DMD or current treatment with natalizumab or fingolimod, or 4) switch to a different DMD. Patients are included in the SMSC only after a written informed consent is signed. Every effort is made to reduce drop-outs to a minimum. If a patient moves to another place within Switzerland, the original centre arranges a consultation with the nearest participating centre.
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Publication 2016
Fingolimod Natalizumab Neuromyelitis Optica Patients Physicians Syndrome
Patients reporting a diagnosis of MS were recruited from an online community, PatientsLikeMe. The site has been described previously [30 (link)-32 (link)]. This online system allows patients with serious illnesses to share their symptoms, treatments, and outcome measures of interest (functional disability, weight, quality of life) in an open medical platform. Patients evaluate their perceptions of treatments, including perceived effectiveness, side effects, burden, and adherence, and can also participate in clinical research. The website features a survey tool, PatientsLikeMeLens, which allows selection of participant lists and online administration of surveys.
The following information is provided to comply with the Checklist for Reporting Results of Internet E-Surveys [33 (link)]. Patients who had logged on to the site in the preceding 90 days were randomly selected to participate, from an overall pool of approximately 15,000 registered MS patients. On December 21, 2009, six blocks of approximately 200 survey invitations were sent to patients reporting current DMT use on their patient profiles for the following groups: not currently taking a DMT (No DMT), glatiramer acetate (GA; Copaxone, Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel), interferon beta-1a intramuscular injection (IFB-1a IM; Avonex, Biogen Idec, Weston, MA, USA), interferon beta-1a subcutaneous injection (IFB-1a SC; Rebif, EMD Serono Inc, Rockland, MA, USA), interferon beta-1b subcutaneous injection (IFB-1b SC, Betaseron, Bayer Healthcare, Leverkusen, Germany), and natalizumab infusion (Tysabri, Biogen Idec). The invitation was sent as a private message within the PatientsLikeMe community, with a customized research invitation message arriving in members’ email inboxes.
New private messages trigger an automated email to patients’ email accounts (unless they have opted out of being contacted in this way). Sampled patients had their own password-protected login; they could complete the survey only once, and we have tools to prevent multiple accounts originating from the same location, including account registration, cookies, and internet provider tracing. Therefore, we have more confidence in our denominators than might be found using an “open” survey method. The survey was voluntary to complete and was not mandatory to complete in order to continue using the other features of the site. No incentives were offered; question order was not randomized; certain items only appeared conditional on previous responses (ie, were “adaptive”) to minimize respondent burden (see Multimedia Appendix 1); and the total number of questions and screens varied by participants’ own responses.
Following initial contact, a reminder message was sent within a week to those who had not yet completed the survey; patients who had only partially completed the survey could reaccess it through the original private message (or reminder message) to complete their survey. Once opened, the survey had a “back” button that allowed participants to change their earlier answers. Only data from completed questionnaires are presented here. The study was approved by Western Institution Review Board (WIRB), Olympia, WA, USA (Study 1111772). Patients gave informed consent electronically.
Members of PatientsLikeMe join the site with the expectation that they will be participating in research. The recruitment message outlined the purpose of the study and reminded patients that they were under no obligation to participate, that their aggregated results may be published, and that the survey should take about 20 minutes to complete. It was sent from the user account for PW, who can easily be contacted by potential participants from within the PatientsLikeMe system.
User data were protected in accordance with PatientsLikeMe’s internal security standard operating procedures, which include password protection, deidentification of locally held data files, regular automated backup, and physical protection of information technology hardware.
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Publication 2011
Acclimatization ARID1A protein, human Avonex beta-1a, Interferon Betaseron Cardiac Arrest Conditioning, Classical Copaxone Diagnosis Disabled Persons Ethics Committees, Research Glatiramer Acetate Interferon beta 1b Intramuscular Injection Natalizumab olympia Patients Physical Examination Precipitating Factors Rebif Secure resin cement Subcutaneous Injections Tysabri

Most recents protocols related to «Natalizumab»

This was a retrospective claim-based cohort study that utilized longitudinal claims data from the HealthCore Integrated Research Database® (HIRD®) from January 1, 2016 to August 31, 2019. The HIRD® contains data from January 2006 on patient enrollment, inpatient and outpatient medical care, prescription, and health care utilization. It is a large longitudinal medical and pharmacy claims database of health plan members comprising all regions of the US.
The data were accessed and used in full compliance with the relevant provisions of the Health Insurance Portability and Accountability Act. The study was conducted under the research provisions of Privacy Rule 45 CFR 164.514(e). Researchers’ access to claims data was limited to data stripped of identifiers to ensure confidentiality. An Institutional Review Board did not review the study since only this limited data set was accessed. This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Pharmacoepidemiology Practices as well as legal and regulatory requirements.
Adult patients aged ≥ 18 years with CD (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] diagnosis codes: K50.x) or UC (ICD-10-CM diagnosis codes: K51.x) who initiated an advanced therapy during the index period of July 1, 2016 through August 31, 2018 were included in the study. Index date was defined as the first observed occurrence of a claim (medical or pharmacy) for any eligible advanced therapy during the index period. For patients who started more than one therapy, only the earliest one observed was used. Included patients were enrolled in commercial, Medicare Advantage, or Medicare Supplemental plus Part D insurance plans for ≥ 6 months before the index date (pre-index period) and ≥ 12 months after index date (follow-up period). Eligible patients were required to have ≥ 2 medical claims for CD or UC from a provider of any specialty at least seven days apart during the study period, of which ≥ 1 claim occurred during the pre-index period.
In this study, advanced therapies for CD included TNFi (adalimumab, certolizumab, infliximab) and non-TNFi (natalizumab, ustekinumab, vedolizumab). For UC, advanced therapies included TNFi (adalimumab, golimumab, infliximab), non-TNFi (vedolizumab; ustekinumab as a potential switcher but not index drug), and other therapies (tofacitinib). Conventional therapies included 5-aminosalicylic acid derivatives (mesalazine and sulfasalazine) and immunosuppressants (azathioprine, methotrexate, mycophenolate, cyclosporine, tacrolimus, 6-mercaptopurine).
Patients were excluded if they had claims for ≥ 1 advanced therapy during the 6-month pre-index period to identify new initiators of advanced therapy. Patients who had evidence for other autoimmune diseases including psoriasis, lupus, ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis (defined as ≥ 2 claims on different dates for the same disease) were also excluded in order to avoid misclassification of the estimated response rate (e.g., related to non-adherence) due to multiple indications.
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Publication 2023
Adalimumab Adult Ankylosing Spondylitis Arthritis, Psoriatic Autoimmune Diseases Azathioprine Care, Ambulatory Certolizumab Pegol Cyclosporine derivatives Diagnosis Ethics Committees, Research golimumab Health Planning Immunosuppressive Agents Infantile Neuroaxonal Dystrophy Infliximab Inpatient Insurance, Medigap Lupus Vulgaris Mercaptopurine Mesalamine Methotrexate Natalizumab Patient Acceptance of Health Care Patients Pharmaceutical Preparations Psoriasis Rheumatoid Arthritis Sulfasalazine Tacrolimus Therapeutics tofacitinib Ustekinumab vedolizumab
A first cohort of patients with multiple sclerosis diagnosed at the multiple sclerosis centre of the Nantes University Hospital consisted of 179 multiple sclerosis patients with disease duration of 8.8 ± 0.5 years (range: 0.1–28) including 149 with a relapsing–remitting form and 30 with a secondary/primary progressive form. The gender ratio was 115F/64M and the average age of 42 ± 1 years (range: 19–73). Four patients were treated with glatiramer acetate, four with dimethylfumarate, 9 with natalizumab, 9 with an S1P modulator, 13 with mycophenolate mofetil, 13 with teriflunomide and 17 with interferon beta. The sera from 86 healthy volunteers (HV gender ratio, 65F/21M; age, 36 ± 1 years, range: 20–65) collected at the same time were processed simultaneously. The second cohort consisted of patients that presented, at time of blood sampling, a clinically isolated syndrome (CIS), defined as a first mono- or multifocal neurological deficit lasting for more than 24 h and not associated with fever or infection, thus compatible with a first presentation of multiple sclerosis.32 (link),33 (link) Clinically isolated syndrome patients from UCLouvain34 (link) and from the Nantes Hospital were used. The gender ratio was 70F/15M and the average age of 41 ± 1 years (range: 17–78). None were under treatment at blood sampling. Sera from 41 HV (gender ratio, 34F/7M; age, 38 ± 2 years, range: 25–62) received at the same time were processed simultaneously. All sera were coded, alternating HV and patients to allow an appropriate repartition for serum testing in each ELISA plate. Sera were coded and kept at −20°C until use. All donors from the Nantes Hospital provided informed consent in compliance with the Declaration of Helsinki and our local hospital ethical committee. Samples from the Cliniques Universitaires Saint-Luc (UCLouvain) were obtained in conformity with local regulatory and ethical requirements for the residual use of serum samples collected for routine diagnostic procedures or patient care, without additional requirement for informed consent (ethical approval 2007/10SEP/233).
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Publication 2023
Diagnostic Tests, Routine Dimethyl Fumarate Donors Enzyme-Linked Immunosorbent Assay Fever Gender Glatiramer Acetate Healthy Volunteers Infection Interferon, beta Multiple Sclerosis Mycophenolate Mofetil Natalizumab Patient Isolation Patients Serum Syndrome teriflunomide
CSF
and serum samples were collected from 22 SPMS, 18 PPMS, at the time
of disease progression confirmation, and 13 controls at the Neurology
Unit of the “Virgen de la Macarena” University Hospital
in Seville, using standardized protocols. All samples were collected,
coded, and stored in the hospital biobank, from where they were sent,
anonymized, to the NMR Unit for analysis. All study subjects signed
the informed consent form for research on biobanked samples, which
was approved by the Ethics Committee of the Hospital, prior to participation
in the study. MS patients were classified according to the 2017 revised
McDonald criteria.2 (link) Control subjects were
patients whose diagnosis required the collection of CSF samples but
whose conditions were not considered to be neurodegenerative in nature.
The absence of unrecognized neurodegeneration or neuroinflammation
among controls was subsequently confirmed with low concentrations
of neurofilament light (NFL) and YKL-40 in their CSF. All samples
were stored at −80 °C until analysis.
None of the
PPMS patients were under any treatment at the time of sample collection,
and only four of them were taking a combination of B vitamin supplementations
(B12, B6, and B1). As for the SPMS patients, only 4 of the 22 patients
were under treatment, 1 with interferon beta-1b and 3 with natalizumab.
Furthermore, one of the patients under natalizumab was also supplemented
with B vitamins, and another patient was only supplemented with the
same combination of B vitamins. The rest of the SPMS patients had
been without any type of treatment for at least a year.
Publication 2023
CHI3L1 protein, human Diagnosis Disease Progression Ethics Committees, Clinical Interferon beta 1b Light Natalizumab Nerve Degeneration Neurofilaments Patients Serum Specimen Collection Vitamin B Complex Vitamins
In 2014–2015, patients with MS (diagnosed with 2010 McDonald criteria27 (link)) were recruited at the National MS Center Melsbroek (NMSC) and University Hospital of Brussels (UZB) for a prospective study. To participate in the study, patients needed to be either treatment naïve, currently untreated (having stopped treatment for at least 3 months if previously treated with glatiramer acetate and at least 6 months if previously treated with fingolimod or natalizumab) or being treated with interferon-β (IFN-β). Antibiotic use 4 weeks before baseline, chronic gastrointestinal disease, and systemic corticosteroid use 2 months before baseline were exclusion criteria for this study. At baseline and 3 months post-baseline, participants provided a fecal sample, filled in questionnaires, and underwent clinical neurological assessments including the expanded disability status scale (EDSS)28 (link) score, the nine-hole peg test (9-HPT)29 (link) and the timed 25-foot walk (T25FW).30 (link) At baseline, patients had a blood draw for neurofilament light chain (NfL) measurement. Neurological assessments were repeated during study visits at 1, 2 and 4–5 y post-baseline. In in-between study visits, clinical assessments were performed in the context of regular follow-up at the NMSC or UZB.
Publication 2023
Adrenal Cortex Hormones Antibiotics BLOOD Disabled Persons Disease, Chronic Feces Fingolimod Foot Glatiramer Acetate Interferon, beta Natalizumab NEFL protein, human Neurologic Examination Patients

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Publication 2023
Antibodies Blood COVID 19 Diagnosis Dimethyl Fumarate Ethics Committees Fingolimod Glatiramer Acetate Immunoglobulins Immunologic Deficiency Syndromes Immunomodulation Immunosuppression Immunosuppressive Agents Interferon, beta Natalizumab Patients Polymerase Chain Reaction Respiratory Tract Infections Rituximab RNA, Messenger SARS-CoV-2 Syndrome teriflunomide Vaccination Vaccines

Top products related to «Natalizumab»

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More about "Natalizumab"

Natalizumab is a monoclonal antibody medication utilized in the treatment of relapsing-remitting multiple sclerosis (RRMS) and Crohn's disease.
It functions by blocking the interaction between α4-integrin and its ligands, preventing the migration of immune cells into the central nervous system (CNS) and reducing inflammation.
This mode of action has been demonstrated to decrease the frequency of relapses and slow the progression of disability in patients with RRMS.
However, Natalizumab carries a risk of potentially serious side effects, including progressive multifocal leukoencephalopathy (PML), necessitating careful monitoring during treatment.
The future of Natalizumab research optimization can be enhanced through the use of PubCompare.ai, a leading AI-driven platform.
PubCompare.ai can assist researchers in locating relevant protocols from literature, pre-prints, and patents, and provide AI-driven comparisons to identify the best protocols and products.
This can improve the reproducibility and accuracy of Natalizumab studies, leveraging the power of PubCompare.ai's curated data and intelligent analysis.
In the context of Natalizumab research, various related tools and techniques may be employed, such as Maxisorb ELISA plates for antibody detection, FACSCalibur for flow cytometry analysis, Ficoll-Paque PLUS for cell separation, Tim Trio for cell culture, RPMI 1640 medium for cell maintenance, L-Glutathione (GSH) for antioxidant support, Ab78502 and P0214 for protein detection, and CellTracker Orange CMRA for cell labeling.
The integration of these specialized tools and techniques can enhance the efficacy and precision of Natalizumab-related studies, ultimately contributing to the advancement of this important therapeutic approach.
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