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Analysis of Lymphocyte Cell Surface Adhesion Marker Expression in Natalizumab Population With Active Control

12 juni 2013 bijgewerkt door: John F. Foley, MD

Analysis of Lymphocyte Cell Surface Adhesion Marker Expression in a Natalizumab Treated Population With Active Control Assessment

The purpose of the study is to research the association between receiving Tysabri® (natalizumab), interferon beta-1a, glatiramer acetate or not having any treatment for your MS and how it may or may not impact certain white blood cells and other immunological markers. This information may be useful in identifying risk factors in developing progressive multifocal leukoencephalopathy (PML). It does appear that the risk increases with the total number of natalizumab infusions. Patients who have not yet started a disease modifying therapy or who have been on one other than natalizumab are needed as controls to see how these biomarkers change.

Patients at various stages of natalizumab treatment as well as natalizumab naïve are needed to allow for analysis of the change in potential markers over time.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

Patients at various timepoints in their MS treatment or who are beginning certain MS treatments will be consented and have blood specimens collected to allow for an immunological comparison. The decision to treat with disease modifying therapies is made independently from this observational study.

Primary endpoint: To further understand the delineation of lymphocyte cell adhesion marker down regulation within a treatment naïve patient population and at various stages of treatment.

Secondary endpoint: To understand the correlation between natalizumab pharmacodynamics, pharmacokinetics and lymphocyte cell adhesion marker down regulation.

The results of various biomarkers and immunological testing (including CD62L, LFA-1, sCD62L, sLFA-1, sVCAM, VLA-4 saturation, IgG4, CBC with absolute differential) will be compared amongst the groups consented. The treatment naive group will be compared longitudinally.

Studietype

Observationeel

Inschrijving (Werkelijk)

164

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84103
        • Rocky Mountain MS Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated at Rocky Mountain Multiple Sclerosis Clinic, and who are currently undergoing disease modifying therapy, natalizumab, glatiramer acetate injections, interferon beta 1a, or who are beginning one of these disease modifying therapies.

Beschrijving

Inclusion Criteria:

  1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  2. Aged 18 to 80 years old, inclusive, at the time of informed consent.
  3. Patients with a relapsing form of Multiple Sclerosis as determined by the treating or back-up neurologist per chart review.
  4. If getting natalizumab or scheduled to commence natalizumab infusion the patient must be enrolled in the TOUCH Prescribing Program and who is not expected to discontinue Tysabri® therapy prior to completion of the requirements of this study or must be currently prescribed and using interferon beta 1a or glatiramer acetate injections for 18 months; or, naïve to natalizumab, interferon beta 1a or glatiramer acetate and beginning treatment after consent.
  5. Patients screened for Group A must be completely naïve to natalizumab, patients beginning interferon beta-1a or glatiramer acetate must also be naïve to natalizumab.
  6. Patients screened for natalizumab naïve must have at least 30 days clear of other disease modifying therapies.
  7. Patients must be free of known systemic bacterial or viral infections.
  8. No fever over 99.5 degrees Fahrenheit in the last two weeks or at Baseline or prior to any scheduled specimen collection.
  9. No herpes zoster outbreaks within the last 30 days.
  10. No methylprednisolone sodium succinate infusion (solumedrol) or corticosteroid use within the last 30 days.
  11. Must weigh between 44 and 190 kg, inclusive.

Exclusion Criteria:

  1. Patient is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
  2. Patients experiencing a MS relapse or exacerbation which results in methylprednisolone sodium succinate infusion 30 days prior to Baseline
  3. Patients with active, unknown infection etiology - if a patient is being treated for a known infection this would be allowed at the discretion of the Investigator, but if they present with signs of infection that has not been diagnosed they should be excluded.
  4. Fever of 99.6 or higher within the last two weeks prior to any of the scheduled specimen collection (Baseline, 1 month, 3 month, 12 month or 18 month).
  5. If patient has missed doses of their DMT as per the inclusion criteria.
  6. No prior immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate mofetil).
  7. Specimen collection must occur Monday through Thursday.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Group A TX Naive
Patient decided to start disease modifying treatment, either interferon beta-1a, glatiramer acetate or natalizumab. If interested and consented they would be assigned to Group A. Patient would have blood specimens taken up to 5 times over the next 19 months: Day 0; Day 28; Day 84: Day 336 and Day 508.
Group B TY 4-12 doses
Patient is currently prescribed and is taking natalizumab, has 4 to 12 doses. If interested patient could be consented and assigned to Group B. Patients will have their blood drawn Day 0; and around the time of the patient's 18th dose.
Group C 18 plus TY
Patient currently or close to being at 18 doses or 18 plus doses of natalizumab. If interested patient consented and assigned to Group C. Patient will have their blood drawn once: Day 0.
Group D Other DMT 18 plus
Patient is close to or currently at 18 doses or more of interferon beta-1a or glatiramer acetate. If interested patient consented and assigned to Group D. Patient will have their blood drawn once: Day 0.
Group E - Non-MS
10 participants without Multiple Sclerosis or other immunological illness. If interested participants consented and assigned to Group E. Participants will have their blood drawn once: Day 0.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Quantitative Assessment of CD62L in MS Patients on Immunomodulatory Agents
Tijdsspanne: 12 Months
12 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: John F Foley, MD, Rocky Mountain MS Research Group, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2012

Primaire voltooiing (Werkelijk)

1 maart 2013

Studie voltooiing (Werkelijk)

1 april 2013

Studieregistratiedata

Eerst ingediend

20 juni 2012

Eerst ingediend dat voldeed aan de QC-criteria

21 juni 2012

Eerst geplaatst (Schatting)

22 juni 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

14 juni 2013

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2013

Laatst geverifieerd

1 juni 2013

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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