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

12 juin 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

164

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Utah
      • Salt Lake City, Utah, États-Unis, 84103
        • Rocky Mountain MS Clinic

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Quantitative Assessment of CD62L in MS Patients on Immunomodulatory Agents
Délai: 12 Months
12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Collaborateurs

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2012

Achèvement primaire (Réel)

1 mars 2013

Achèvement de l'étude (Réel)

1 avril 2013

Dates d'inscription aux études

Première soumission

20 juin 2012

Première soumission répondant aux critères de contrôle qualité

21 juin 2012

Première publication (Estimation)

22 juin 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

14 juin 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 juin 2013

Dernière vérification

1 juin 2013

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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