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Tysabri Medical Research Studies

Up-to-date List of Tysabri Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Tysabri Medical Research Studies

Rank Status Study
1 Recruiting Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Drug: Tysabri
Outcome Measure: specific MRI parameters and RNFL (retinal nerve fiber layer) thickness in OCT optical coherence tomography in correlation with cognition measurements
2 Recruiting TOP: IMA-06-02 Tysabri Observational Program
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: Natalizumab
Outcome Measures: Occurrence of SAE other than MS relapse;   occurrence of relapses;   EDSS progression;   assessment of baseline variables as a prognostic factor;   anti-JC virus (JCV) antibody prevalence
3 Not yet recruiting Immunogenicity and Safety Study of Natalizumab (BG00002) Administered to Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
Intervention: Drug: BG00002 (natalizumab)
Outcome Measures: Proportion of subjects with persistent anti-natalizumab antibodies;   Proportion of participants with transient anti-natalizumab antibodies;   Proportion of participants with post-injection adverse events (AEs);   Proportion of participants with clinical relapse;   Proportion of participants with gadolinium (Gd) enhancing lesion(s);   Proportion of Participants that experience Adverse Events and Serious Adverse Events
4 Recruiting PK and PD Study of Natalizumab in Pediatric Subjects With RRMS
Condition: Relapsing-Remitting Multiple Sclerosis
Intervention: Biological: Natalizumab
Outcome Measures: predose (trough) concentrations from multiple dosing (Cpredose);   maximum plasma concentration (Cmax);   time to maximum plasma concentration (Tmax);   area under the plasma concentration curve from time of first dose to infinity (AUCinf);   apparent clearance (Cl/F);   volume of distribution;   elimination half-life (t1/2);   the average and minimum saturation values of α4 integrin over the dosing interval;   incidence of serious adverse events (SAEs), infusion and hypersensitivity reactions, and other AEs;   the presence of anti-natalizumab antibodies
5 Recruiting The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention: Drug: Tysabri ® (Natalizumab)
Outcome Measures: Sexual Dysfunction;   Sexual Function;   Fatigue;   Quality of Life
6 Recruiting CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring
Condition: Crohn's Disease
Intervention: Drug: Natalizumab
Outcome Measures: Incidence of serious and/or clinically significant infections, malignancies, and other SAEs in patients with CD treated with Tysabri®;   Disease severity over time in CD patients treated with Tysabri®.
7 Not yet recruiting Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease
Condition: Acute Graft Versus Host Disease
Interventions: Drug: natalizumab;   Drug: steroids
Outcome Measures: Complete Response (CR);   Overall survival (OS);   Non-Relapse Mortality (NRM);   incidence of treatment-refractory GVHD;   Time to discontinuation of steroid therapy;   Number of additional GVHD therapies;   Number of serious infections;   Overall response rate (CR + PR)
8 Recruiting Ireland Tysabri® (Natalizumab) Observational Program (iTOP)
Conditions: Multiple Sclerosis, Relapsing-Remitting;   Relapsing Remitting Multiple Sclerosis
Intervention:
Outcome Measures: The number of participants that experience serious adverse events (SAEs);   Proportion of Participants Whose Multiple Sclerosis Progresses at least 1 Point on the Expanded Disability Status Score (EDSS) and Sustained Over 6 Months;   Proportion of Participants that Reach Expanded Disability Status Score (EDSS) Milestones Indicating Increasing Disability;   Proportion of Participants Whose Expanded Disability Status Score (EDSS) Worsened, Stabilized or Improved and Sustained over 6 Months;   Annualized Relapse Rate;   Distribution of the Total Number of Relapses During the Study;   Time to First Relapse;   Proportions of Participants with relapse;   Multiple Sclerosis (MS) Disability Progression and MS Disease Activity Summarized for Subpopulations According to Baseline Characteristics
9 Recruiting Pregnancy Exposure Registry for Tysabri
Conditions: Multiple Sclerosis;   Prenatal Exposure;   Pregnancy
Intervention:
Outcome Measure: Pregnancy Outcomes: Spontaneous Abortions, Birth Defects
10 Unknown  BG00002 Study in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis
Interventions: Biological: BG00002;   Biological: Placebo
Outcome Measures: Measurement of new active lesions on cranial MRI scans;   Frequency of clinical exacerbations as a measure of MS status;   Number of lesions on MRI as a measure of MS status;   Number of relapses as a measure of MS status;   Changes in patient assessed outcomes;   Concentration of BG0002 in serum;   Incidence of serum antibodies to BG00002;   Degree of receptor saturation by BG0002
11 Not yet recruiting Alternative Treatment Paradigm for Natalizumab Trial
Condition: Multiple Sclerosis (MS)
Intervention: Drug: methylprednisolone
Outcome Measures: annualized relapse rate;   restoration of immune homeostasis - evaluated by regular brain MRI with contrast at baseline, month6 and month 12 of the study
12 Recruiting Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
Intervention:
Outcome Measures: Multiple Sclerosis Impact Scale-29;   Annualized Relapse Rate at each analysis timepoint and change from Baseline;   Expanded Disability Status Scale (EDSS) change over time;   Work Productivity and Activity Impairment at each analysis timepoint and change from Baseline;   EuroQol 5-Dimension at each analysis timepoint and change from Baseline;   Subject Global Assessment of Wellbeing Visual Analog Scale at each analysis timepoint and change from Baseline;   Clinical Disease-Free Status (relapses, EDSS) at each analysis timepoint
13 Unknown  Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab
Conditions: Multiple Sclerosis;   Cognitive Impairment
Intervention:
Outcome Measures: The Symbol Digit Modalities Test (SDMT);   Multiple Sclerosis Inventory Cognition (MUSIC);   TAP subtest Alertness;   Composite neurocognitive index
14 Recruiting Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis
Condition: Multiple Sclerosis
Intervention:
Outcome Measures: Disease free patients;   comparing the efficacy of Natalizumab with that of Fingolimod with regard to the annual incidence rate (comparison against the annual incidence rate criterion after 1 year
15 Recruiting Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Condition: Relapsing-remitting Multiple Sclerosis
Intervention:
Outcome Measures: Proportion of patients who are overall disease activity-free;   Proportion of patients who are clinical disease activity-free;   Identification of baseline prognostic factors that predict overall disease-free status;   Identification of yearly prognostic factors that predict overall disease-free status;   Clinical disease-free status;   Identification of baseline prognostic factors that predict clinical disease-free status;   Identification of yearly prognostic factors that predict clinical disease-free status;   Annualized Relapse Rate (ARR);   Sustained EDSS progression;   Sustained EDSS improvement;   MRI T2 measure;   MRI T1 measure;   MRI T1 with Gadolinium-enhancing measure;   MRI brain atrophy measure;   Retinal nerve fiber layer thickness measured by Optical Coherence Tomography (OCT);   Low Contrast Visual Acuity assessment;   Cognitive impairment as measured with the Symbol Digit Modalities Test (SDMT);   Capacity for work as measured by the Work Productivity and Activity Impairment (WPAI) questionnaire;   Quality of Life as measured by the Multiple Sclerosis Impact Scale (MSIS-29)
16 Recruiting Safety and Effectiveness of Switching Relapsing MS Patients Treated With Natalizumab at Risk for PML to Teriflunomide
Condition: Multiple Sclerosis
Intervention: Drug: teriflunomide
Outcome Measures: Proportion of patients relapse free at 12 months;   Time to return of radiological evidence of MS activity with new Gd+ lesions on cranial MRI.;   EDSS sustained progression for 3 months as measured by at least 0.5 increase from baseline or 1 in any EDSS set score;   Number of new T2 or enlarging T2 hyperintensities on monthly sentinel brain MRIs
17 Recruiting Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
Interventions: Other: mitoxantrone - immunomodulator;   Other: natalizumab
Outcome Measures: cost effectiveness;   progressive neurological disability
18 Recruiting Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
Condition: Relapsing Remitting Multiple Sclerosis
Intervention:
Outcome Measures: Disease Stability;   Quantify disease stability
19 Recruiting Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
Interventions: Biological: BG00002;   Drug: Placebo
Outcome Measures: Change in Infarct Volume from Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR]);   Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR);   Change in Infarct Volume From 24 hours (DWI) to Day 5 and Day 30 (FLAIR);   Change in National Institute of Health Stroke Scale (NIHSS) Score from Baseline to 24 hours, Day 5, Day 30, and Day 90;   Modified Rankin Scale (mRS) distribution at Day 5, Day 30, and Day 90;   Barthel Index at Day 5, Day 30, and Day 90;   Number of subjects who experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
20 Recruiting Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
Condition: Progressive Multifocal Leukoencephalopathy
Intervention:
Outcome Measures: to examine host genetic variation and possible genetic susceptibility to PML;   To explore predisposing factors of the innate and adaptive immune system;   To analyze DNA sequences of JCV;   optional substudy: to test alterations in DNA repair pathways

These studies may lead to new treatments and are adding insight into Tysabri etiology and treatment.

A major focus of Tysabri research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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